Atlas FDA

2000

3,453 FDA 510(k) clearances · Clearance year

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RecordFirmDate
CELL-CHEX (K000076)Streck Laboratories, Inc.2000-03-03
PULPDENT CAVITY PREPARATION III (K994180)Pulpdent Corp.2000-03-02
MEDLINE BREATHABLE, IMPERVIOUS DISPOSABLE SURGICAL GOWNS (K993170)Medline Industries, Inc.2000-03-02
TERUMO NEEDLE WITH LOCKING SHEATH (K000387)Terumo Medical Corp.2000-03-02
BACT/ALERT MB CULTURE BOTTLE (K000378)Organon Teknika Corp.2000-03-02
MULTISAFE POWDERED LATEX EXAMINATION GLOVES, NONSTERILE (K993811)Multisafe Sdn. Bhd.2000-03-02
SAFESKIN PFE-XTRA POWDER-FREE LATEX EXAMINATION GLOVES, PROTEIN CONTENT 50 MCG OR LESS, FOR USE WITH CHEMOTHERAPEUTIC AG (K993117)Safeskin Corp.2000-03-02
SEPRAMESH BIOSURGICAL COMPOSITE, MODEL SMBC-XXX (K994328)Genzyme Corp.2000-03-02
TOOTHBRUSH WASH (K994144)Cal Huech, Inc.2000-03-02
HYLASHIELD CL (K994170)Biomatrix, Inc.2000-03-02
UBAS (K993941)Marukin Diagnostics2000-03-02
TRIAGE BNP CALIBRATION VERIFICATION CONTROLS (K000231)Biosite Incorporated2000-03-02
HARDYDISK, CARBENICILLIN, 100MCG (K000181)Hardy Diagnostics2000-03-02
DISPOSABLE POWDER FREE NITRILE EXAM GLOVES, WHITE COLOR (K000226)Sheen More Ent. Co., Ltd.2000-03-02
MRI- FLOW ANALYTICAL SOFTWARE PACKAGE (K994282)Medis Medical Imaging Systems BV2000-03-02
HARDYDISK TICARILLIN 75MCG (K000175)Hardy Diagnostics2000-03-02
CYTOPLAST RESORB, MODELS R-250, RP-250, RU-250, RPS-250, RPL-250 (K993610)Osteogenics Biomedical, Inc.2000-03-02
MIKRO-TIP ANGIOGRAPHIC CATHETER (K993694)Millar Instruments, Inc.2000-03-01
MDI DS-DNA TEST (K000477)Micro Detect, Inc.2000-03-01
OVUM PICK-UP NEEDLES WITH AQ COATING, ASPIRATION NEEDLES WITH AQ COATING (K994417)Cook Urological, Inc.2000-03-01
ADVANTA SUPER SOFT GRAFT (K000499)Atrium Medical Corp.2000-03-01
ADVANTA SUPER SOFT GRAFT (K000504)Atrium Medical Corp.2000-03-01
PATIENT CABLES FOR MONITORING, I.E., ECG, EKG, SPO2, AND BP INTERFACE CABLES AND LEADWIRES (K992524)Advantage Medical Electronics, Inc.2000-03-01
DIMENSION C3 FLEX REAGENT CARTRIDGE (K994296)Dade Behring, Inc.2000-03-01
MPT 24 AND VITAL VIEW 24 (K000276)Criticare Systems, Inc.2000-03-01
STAPLETAC2 BONE ANCHOR SYSTEM (K000279)American Medical Systems, Inc.2000-03-01
NAC Y-ADP (K000343)The Kipp Group2000-03-01
CHILLBUSTER PORTABLE ELECTRIC BLANKET SYSTEM, MODEL 8001 (K991684)Thermogear, Inc.2000-03-01
PERCUTX-INJECTION/ASPIRATION NEEDLE PROBES/DEVICES (K994151)Ximed/Prosure/Injectx2000-03-01
DIMENSION C4 FLEX REAGENT CARTRIDGE (K994293)Dade Behring, Inc.2000-03-01
PHALANGEAL FIXATION SYSTEM (K994232)Medcanica, Inc.2000-03-01
MERCURY MEDICAL DISPOSABLE RADIOFREQUENCY CANNULA (K000073)Mercury Medical2000-03-01
MODIFIED HYDROPHILIC COATED GUIDEWIRE (K000011)Lake Region Mfg., Inc.2000-03-01
DIMENSION SPECIAL PROTEIN CALIBRATOR (K994291)Dade Behring, Inc.2000-03-01
LEMAITRE VENOUS THROMBECTOMY CATHETER (K992934)Vascutech, Inc.2000-03-01
VOCOM IMPLANT- 8MM (K000533)Smith & Nephew, Inc.2000-03-01
MEDAMICUS EPIDURAL INTRODUCER (K994097)Medamicus, Inc.2000-03-01
CARDIOPULMONARY BYPASS PUMP TUBING - 1/4 INCH TUBING, CARDIOPULMONARY BYPASS PUMP TUBING - 3/8 INCH TUBING (K993189)Terumo Corp.2000-03-01
SUPERSTITCH (K994087)Sutura, Inc.2000-03-01
CROSS LINKED POLYETHYLENE ACETABULAR COMPONENTS,MODEL XX-YY-ZZZZZZ (K990330)Implex Corp.2000-03-01
REFLEX TREATMENT SYSTEM (K994079)Deschutes Medical Products, Inc.2000-03-01
QUICKAIR CHOKE RELIEVER, MODEL 59-001A (DEN000004)Maet Industries, Inc.2000-02-29
HARDYDISK, NALIDIXIC ACID, 30MCG (K000130)Hardy Diagnostics2000-02-29
TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) CONTROLS (K000230)Biosite Incorporated2000-02-29
HARDYDISK, STREPTOMYCIN 10MCG (K000201)Hardy Diagnostics2000-02-29
HARDYDISK TOBRAMYCIN, 10MCG (K000182)Hardy Diagnostics2000-02-29
DENTAL IMPLANT (K992937)Nobel Biocare Uas, Inc.2000-02-29
SECURMIX (K000367)Eurospital2000-02-29
CEMENT IT! UNIVERSAL C&B (K000173)Jeneric/Pentron, Inc.2000-02-29
KIPPMED I.V. MANIFOLD (K000152)The Kipp Group2000-02-29
MODIFICATION OF REGULAR DIAMETER SINGLE STAGE (RDS) TPS DENTAL IMPLANT SYSTEM (K994205)Lifecore Biomedical, Inc.2000-02-29
PULPDENT CAVITY PREPARATION II, PULPDENT CAVITY PREPARATION II WUTH FLUORIDE (K994181)Pulpdent Corp.2000-02-29
CRAFT DUO-VAC SUCTION UNIT AND CRAFT SUCTION UNIT (K000394)Rocket Medical Plc2000-02-29
HYBRID CAPTURE II CT/GC TEST (K981567)Digene Corp.2000-02-29
SYNTHETIC POWDER FREE (WHITE) VINYL PATIENT EXAMINATION GLOVES (K000071)Shijiazhuang Great Eagle Plastic Products Co., Ltd.2000-02-29
BIONOSTICS GLUCOSE QUALITY CONTROL SOLUTION FOR USE WITH THE FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM (K000318)Bionostics, Inc.2000-02-28
EMBRYON TRANSFER CATHETERS/SETS (K994327)Rocket Medical Plc2000-02-28
DRYSPOT E.COLI 0157 KIT (K993401)Oxoid , Ltd.2000-02-28
IMMULITE PHENYTOIN, IMMULITE 2000 PHENYTOIN, CATALOG # LKPN1, LKPN5 & L2KPN2, L2KPN6 (K000006)Diagnostic Products Corp.2000-02-28
BLACKSTONE SPINAL FIXATION SYSTEM (K994217)Blackstone Medical, Inc.2000-02-28
MODIFICATION TO T-REX BIOPSY FORCEPS (K000409)Boston Scientific Corp2000-02-28
HARDYDISK, PIPERACILLIN, 100MCG (K000183)Hardy Diagnostics2000-02-28
NEURO URODYNAMIC SUITE, MODEL 9032E0101 (K992715)Medtronic Functional Diagnostics A/S2000-02-28
TRIPLE-FIX SPINAL FIXATION SYSTEM (K992147)Advanced Spine Technology, Inc.2000-02-28
MEDI-CULT FREEZING & THAWING PACKS (K991335)Medicult A/S2000-02-28
ZOLL M SERIES ETCO2 OPTION (K993036)Zoll Medical Corp2000-02-28
IMMULITE CARBAMAZEPINE, IMMULITE 2000 CARBAMAZEPINE, CATALOG # LKCB1, LKCB5 & L2KCB2, L2KCB6 (K000007)Diagnostic Products Corp.2000-02-28
MEDI-CULT SPERM FREEZE MEDIUM (K991333)Medicult A/S2000-02-28
ONEFLOW (K980951)Sti Medical2000-02-25
ROTAGLIDE + MODULAR KNEE SYSTEM WITH FIXED MENISCUS (K000232)Corin USA2000-02-25
CLEEN-ABLE (K994044)Vital Signs, Inc.2000-02-25
MEDI-CULT LIQUID PARAFFIN (K991330)Medicult A/S2000-02-25
CORMET 2000 HEMI HIP METALLIC RESURFACING PROSTHESIS (K994153)Corin USA2000-02-25
PROFI DISPOSABLE SYRINGE, PROFI DISPOSABLE NEEDLE, DM JECT INSULIN SYRINGE (K993017)Shinchang Medical Co., Ltd.2000-02-25
EBI XFIX DFS SYSTEM (K000319)Ebi, L.P.2000-02-25
AFFINITY NT HOLLOW FIBER OXYGENATOR WITH PLASMA RESISTANT FIBER WITH CARMEDA BIOACTIVE SURFACE, MODEL CB511 (K000430)Medtronic Vascular2000-02-25
VERIPATH PERIPHERAL GUIDING CATHETER (K994229)Advanced Cardiovascular Systems, Inc.2000-02-25
ACUFEX SPIKED WASHER SYSTEM, ACUFEX SUTURE WASHER SYSTEM, ACUFEX CANCELLOUS SCREW AND SPIKED WASHER SYSTEM (K994202)Smith & Nephew, Inc.2000-02-25
MALLORY-HEAD MODULAR CALCAR TOTAL HIP SYSTEM (K000335)Biomet, Inc.2000-02-25
MEDI-CULT PVP MEDIUM, MEDI-CULT PVP CLINICAL GRADE (K991329)Medicult A/S2000-02-25
OVOIL-150, MODEL 5002 (K991351)Vitrolife Sweden AB2000-02-25
RADIAL HEAD PROSTHESIS (K992220)Smith & Nephew, Inc.2000-02-25
MEMOGRAPH STAPLE, WARM SYSTEM (K993714)Biomedical Ent., Inc.2000-02-25
MEDEFIL'S NORMAL SALINE FLUSH SYRINGE, IN VARIOUS FILL SIZES - 1 ML FILL IN 3 ML SYRINGE LL; 1 ML FILL IN 6 ML SYRINGE L (K993515)Medefil, Inc.2000-02-25
BIO-LIPID HUMAN SERUM HDL AND LDL CALIBRATORS (K000056)Biocell Laboratories, Inc.2000-02-24
E.N.S.I. SYRINGE (K000572)Tri-Ject Intl. Corp.2000-02-24
DEFINITE (K993514)Degussa - Ney Dental, Inc.2000-02-24
HORTMANN ECHOMASTER OAE ANALYZER (K994033)Hortmann AG2000-02-24
PH-100, MODEL 2104 (K991346)Vitrolife Sweden AB2000-02-24
MA-300 ELECTROMYOGRAPHY SYSTEM (K000220)Motion Lab Systems, Inc.2000-02-24
7250 (MEGAS) (K994369)Biosound Esaote, Inc.2000-02-24
DINAMAP PRO SERIES MONITOR, MODELS 100, 200, 300, 400 (K992638)Critikon Company, LLC2000-02-24
ESC INTENSE PULSED LIGHT SYSTEMS: EPILIGHT AND MULTILIGHT (K994014)Esc Medical Systems , Ltd.2000-02-24
MERETEK UBT_LITE BREATH TEST FOR H. PYLORI (K000316)Meretek2000-02-24
OIS-STAND ALONE DIAGNOSTIC ULTRASOUND SYSTEM (K000034)Optimal Imaging Systems, Inc.2000-02-24
IMMUNOCYT (K994356)Diagnocure, Inc.2000-02-23
MODIFICATION TO MODEL 5866-37M LEAD ADAPTOR KIT (K000210)Medtronic Vascular2000-02-23
ACUVUE (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS CLEAR AND VISIBILITY TINTED WITH UV BLOCKER (K994324)Vistakon, Johnson & Johnson Vision Products, Inc.2000-02-23
ACCU-CHEK COMPLETE METER (K000364)Roche Diagnostics Corp.2000-02-23
SNN STEREOTAXIC PLANNING APPLICATION; SNN STEREOTACTIC APPLICATION (K994421)Surgical Navigation Specialists, Inc.2000-02-23
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Every clearance here is in the API, with alerts when new ones post.