Atlas FDA

2010

2,807 FDA 510(k) clearances · Clearance year

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RecordFirmDate
MULTIPLE NAME MODEL MULTIPLE (K093759)Gx Corporation Sdn Bhd (Plant 1)2010-02-19
PIONEER POSTERIOR CERVICO-THORACIC SYSTEM (K092295)Pioneer Surgical Technology2010-02-19
ELI PC ELECTROCARDIOGRAPH (K093339)Mortara Instrument, Inc.2010-02-19
SONALIS (K100204)Smith Associates2010-02-19
MODELS FORA V30 AND TD-4242 BLOOD GLUCOSE MONITORING SYSTEMS (K093635)Taidoc Technology Corporation2010-02-18
LS-40 CO2 LASER SYSTEM MODEL LS-40 (K093793)Sandstone Medical Technologies, LLC2010-02-18
CLEANER ROTATIONAL THROMBECTOMY SYSTEM (9 MM X 65 CM) AND (9 MM X 120 CM) (K091029)Rex Medical2010-02-18
CARRIGEN (K093447)Etex Corp.2010-02-18
HG II SHORT FIXTURE SYSTEM (K091678)Osstem Implant Co., Ltd.2010-02-18
DIALOG WITH ADIMEA OPTION (K083460)B. Braun Avitum AG2010-02-18
DURASPAN HEMODIALYSIS LONG-TERM CATHETER (K100169)R4 Vascular, Inc.2010-02-18
EDGELOCK (K093900)Orthohelix Surgical Designs, Inc.2010-02-17
CORE-FLO D/C (K093470)Bisco, Inc.2010-02-17
SENSITITRE 18-24HR SUSCEPTIBILITY PLATES (K093865)Trek Diagnostic Systems, Inc.2010-02-17
BIATAIN AGFOAM DRESSINGS-NON-ADHESIV: 5X7CM, 10X10CM, 10X20CM,15X15CM & 20X20CM (K100218)Coloplast A/S2010-02-17
ESTEMP NE (K100290)Spident Co., Ltd.2010-02-17
REVERE STABILIZATION SYSTEM (K093294)Globus Medical, Inc.2010-02-17
RACEGEL (K093711)Septodont2010-02-17
PHILIPS AVALON FETAL MONITORS FM20, FM30, FM40, AND FM50 (K092028)Philips Medizin Systeme Boeblingen GmbH2010-02-17
AUTO SUTURE ENDO CLIP III5MM CLIP ADAPTER (K100242)Surgical Devices, A Division of Tyco Healthcare2010-02-17
JARIT, RUGGLES, R&B REDMOND/ REDMOND, MILTEX, MEISTERHAND - KERRISON RONGEURS (K092227)Integra Lifesciences Corp.2010-02-17
TUMARK PROFESSIONAL, MODEL 271560, MR-TUMARK PROFESSIONAL, MODEL 601560 (K093064)Somatex Medical Technologies GmbH2010-02-17
THE CROSSER S6 CATHETER, THE CROSSER SYSTEM ELECTRONICS, MODEL CRUS6, GEN200 (K092175)Flowcardia, Inc.2010-02-17
XENIUM XPM 110, XENIUM XPM 130, MODELS M25649A, M25650A, XENIUM XPM 150, XENIUM XPM 170 (K093120)Baxter Healthcare Corporation - Renal Division2010-02-17
AFM ULTRA AG DRESSINGS (K093188)Milliken & Co.2010-02-17
PDS PLATES (K092590)ETHICON, Inc.2010-02-17
G-CATH TISSUE ANCHOR DELIVERY CATHETER, MODELS 205302, 205333 (K100251)Usgi Medical2010-02-17
BIOTREND OXYGEN SATURATION AND HEMATOCRIT SYSTEM (K093650)Medtronic, Inc.2010-02-17
ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM (K100138)Alphatec Spine, Inc.2010-02-17
ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM, VERSION 2.0 (K093533)Materialise NV2010-02-17
TROPAZONE CR (K093544)Midlothian Laboratories2010-02-16
SKELTEX ISV (K091234)Skeltex Technologies, Inc.2010-02-16
SCOPE INTRODUCER MODEL 7400 (K093329)N.M. Beale Co., Inc.2010-02-16
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL158BT (K093824)Health & Life Co., Ltd.2010-02-16
3 PIECE PARODI GUIDEWIRE SYSTEM ( LONG CUT OUTER WITH LONG TAPER .014) SHORT TAPER, 2 PIECE PARODI GUIDEWIRE SYSTEM (LON (K093515)Brivant, Ltd.2010-02-16
NON-STERILE DISPOSABLE VAGINAL SPECULUM (K092870)Kunshan Deyi Plastic Co., Ltd.2010-02-16
COLLAGEN SPONGE (K092805)Innocoll Pharmaceuticals2010-02-16
ALPHAHYSTEROSCOPE, FIBEROPTIC, OPERATIVE AND DIAGNOSTIC (K092421)Gimmi GmbH2010-02-12
SELF ADHESIVE COMPOSITE LUTING CEMENT (K093338)Dmg USA, Inc.2010-02-12
MODIFICATION TO CAPSURE PS SYSTEM (K100122)Spine Wave, Inc.2010-02-12
SIMPLISEAL (K093208)Discus Dental, LLC2010-02-12
NON-MYDRIATIC RETINAL CAMERA, MODEL TRC-NW8F (K100207)Topcon Corp.2010-02-12
IMPRESS ANGIOGRAPHIC CATHETER WITH HYDROPHILIC COATING (K093004)Merit Medical Systems, Inc.2010-02-12
CAYMAN SCREWS MODEL K2-12-1000-XX, K2-12-1001-XX (K100061)K2m, Inc.2010-02-12
B12 REAGENT CARTRIDGE AND FOL FLEX REAGENT CARTRIDGE, MODEL RF642 AND RF644 (K093631)Siemens Healthcare Diagnostics2010-02-12
MINI LAP RETRACTORS (K093449)Mini Lap Technologies, Inc.2010-02-12
COMFORTGEL NASAL MASK (K092835)Respironics Inc., Sleep & Home Respiratory Group2010-02-12
WAYPOINT STEREOTACTIC SYSTEM (K092192)FHC, Inc.2010-02-12
GLIDER PTA BALLOON CATHETER (K094019)Trireme Medical, Inc.2010-02-12
MT9000 SERIES ELECTRO-STIMULATOR, MODELS MT9000, MT9002, MT9001, MT9004 AND MT9003 (K093138)Shenzhen Dongdixin Technology Co., Ltd.2010-02-12
MODIFIED STRAIGHT FIRE LASER FIBER (K100078)Boston Scientific Corp2010-02-12
STRAUMANN RC TEMPORARY ABUTMENTS (K093027)Straumann USA2010-02-12
ENDOSCOPE REPROCESSOR OER-PRO (K093106)Olympus Medical Systems Corporation2010-02-12
FLOCHEC PHOTO PLETHYSMOGRAPHIC DEVICE (K093192)Advanced Vascular Dynamics2010-02-12
SR GLOVE, NU GLOVE, HIGHSTRESS MODEL 801, MODEL 802, MODEL 803 (K093696)Central Medicare Sdn Bhd2010-02-12
ELECTRO-LIGHT THERAPY (K090250)Hill Laboratories Co.2010-02-11
JMS BLUNT A. V. FISTULA NEEDLE SET WITH SITE PREPARATION TOOL MODEL 820-5300, 820-6300 AND 820-7300 (K093637)Jms North America Corp.2010-02-09
TCX-I-DV REMOTE CARE MANAGEMENT SYSTEM (K093379)Bl Healthcare, Inc.2010-02-09
ENTELLUS MEDICAL BALLOON DEVICE (K093007)Entellus Medical, Inc.2010-02-05
HEMOSIL D-DIMER HS 500, CONTROLS (K090264)Instrumentation Laboratory CO2010-02-05
FORA G72 BLODO GLUCOSE MONITORING SYSTEM/TD-4264 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4264 (K093005)Taidoc Technology Corporation2010-02-05
ORTHO SELECT BONE PLATES AND SCREW SYSTEM (K091493)Ortho Select Implant Technology Gesellschaft2010-02-05
IQ 20 SERIES ANALYZER, IQ 200 SERIES SYSTEM, NAD IQ LAMINA CRADLE (K093861)Iris International, Inc.2010-02-05
POCKET BVM (K093081)Microbvm Systems , Ltd.2010-02-05
TCM TOSCA MONITORING SYSTEM, TCM COMBIM MONITORING SYSTEM (K093154)Radiometer Medical Aps2010-02-05
SPORT-ELEC BODY CONTROL SYSTEM BS (K092142)Sport-Elec2010-02-05
ACTIVE KNEE TOTAL KNEE REPLACEMENT SYSTEM (K093567)Anova Implant Solutions, LLC2010-02-05
ACECIDE-C HIGH LEVEL DISINFECTANT AND STERILANT (K091210)Best Sanitizers, Inc.2010-02-05
AMPLATZER TORQ VUE 2 DELIVERY SHEATH MODEL 9-TV2-05F120, MODEL 9-TV2-06F120, MODELTV-2-07F120 (K093476)Aga Medical Corp.2010-02-05
OTC TENS FOR ARM AND LEG PAIN RELIEF, MODEL WL-2407 (K091757)Well-Life Healthcare Limited2010-02-05
TRUST DAM (K091769)Line One Laboratories, Inc.2010-02-05
CORIN METAFIX FEMORAL STEM (K082525)Corin USA2010-02-04
CANON, MODEL URS-50RF (K093688)Virtual Imaging, Inc.2010-02-04
UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM (K100070)Depuy Spine, Inc.2010-02-04
NEXUS INJECTION SITE, MODEL NIS-8 (K092527)Nexus Medical, LLC2010-02-04
FIREBIRD SPINAL FIXATION SYSTEM, FIREBIRD SIDE-LOADING BODY (K100044)Blackstone2010-02-04
LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE ELEVATED LINERS (K093846)Zimmer, Inc.2010-02-04
ELECSYS PROBNP II STAT IMMUNOASSAY AND ELECSYS PROBNP II CALSET, MODELS 05390109-160, 04842472-190 (K092649)Roche Diagnostics Corp.2010-02-04
COMPRESSOR FILTER, MODELS AG1038831, HCF100,BF900,BF910,BF950, LL201, LL202, LL205, BACTERIA FILTER (K091363)Ag Industries2010-02-04
OPTEASE VENA CAVA FILTER AND RETRIEVAL CATHETER (K091077)Cordis Corp., A Johnson & Johnson Co.2010-02-04
6F TRIPLE LUMEN POWERLINE CENTRAL VENOUS CATHETER, 5F DUAL LUMEN POWERLINE CENTRAL VENOUS CATHETER (K093927)C.R. Bard, Inc.2010-02-04
OMNISPAN MENISCAL REPAIR SYSTEM/0 DEGREE, MODEL 228140, RAPIDLOC A2 MENISCAL REPAIR SYSTEM/12 DEGREE, MODEL 228141 (K092836)Depuy Mitek, A Johnson & Johnson Company2010-02-04
EXAPACS (K093444)Medincom Technology Corp2010-02-04
VERTOS MEDICAL MILD DEVICE KIT (K093062)X-Sten Corp.2010-02-04
PARI VIOS (K092918)Pari Respiratory Equipment, Inc.2010-02-04
SELECT DEFENSE DENTAL PIT AND FISSURE SEALANT (K093059)Classone Orthodontics, Inc.2010-02-04
OKMETER MATCH BLOOD GLUCOSE MONITORING SYSTEM (K090609)Ok Biotech Co., Ltd.2010-02-04
ESL SPINAL SYSTEM (K092574)Ebi, L.P.2010-02-04
STRONG DENTAL HANDPIECES (K100192)Saeshin Precision Co., Ltd.2010-02-04
TARGET DETACHABLE COILS AND INZONE DETACHMENT SYSTEM (K093142)Boston Scientific Corp2010-02-04
IMMULISA CELIAC G+ (GLIADIN) IGA AND IGG ANTIBODY ELISA (K091522)Immco Diagnostics, Inc.2010-02-04
ANTI-WRINKLE (AGING) LIGHT, MODEL AAL (K092800)Led Intellectual Properties, LLC2010-02-04
SPINE360 ANTERIOR CERVICAL PLATE SYSTEM (K092531)Spine3602010-02-04
R650 QDASM COLLIMATOR (K093572)Omega Medical Imaging, Inc.2010-02-03
NON-STERILE, POWDER-FREE, PINK LATEX EXAMINATION GLOVES WITH AND/OR WITHOUT STRAWBERRY SCENT AND WITH PROTEIN CONTENT (K093496)Oon Corp. Resources2010-02-03
AMPHETAMINES II (K083764)Roche Diagnostics Corp.2010-02-03
MICRONJET 600 (K092746)Nanopass Technologies , Ltd.2010-02-03
MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE 1 UNIT/ML; 10 UNITS/ML; AND 100 UNITS/ML IN VARIOUS FILL SIZES (K092491)Medefil, Inc.2010-02-03
VECTRA PLUS LASER SYSTEM AND ACCESSORIES (K082230)Xintec Corporation2010-02-03
GENERAL PATIENT MONITORS, MODELS: G3C/ G3D/ G3F/ G3G/ G3H (K092970)General Meditech, Inc.2010-02-02
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