Atlas FDA

1995

5,487 FDA 510(k) clearances · Clearance year

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RecordFirmDate
BUSE STAFF PROTECTION GOWNS AND KITS (K941845)Busse Hospital Disposables, Inc.1995-05-10
CVD BULLET INFUSION CATYHETER (K951502)Cardiovascular Dynamics, Inc.1995-05-10
MASTERSTIM 1-4 (K932075)Health Care Assoc.1995-05-10
ANDAL (K950823)Pt. Sarana Indoprotex1995-05-10
ACTIVE IGF-I ELISA (K951752)Diagnostic Systems Laboratories, Inc.1995-05-10
ULTRADENT PORCELAIN ETCH (K951582)Ultradent Products, Inc.1995-05-10
DSL ACTIVE IFGBP-3 ELISA (K951707)Diagnostic Systems Laboratories, Inc.1995-05-10
HEPARIN MANAGEMENT TEST CARD; HMT CARD (K943283)Cardiovascular Diagnostics, Inc.1995-05-10
INTRAORAL VIDEO SCOPE AND WINDOW TUBE (K951019)Cuda Products Co.1995-05-10
NIHON KOHDEN NEUROPACK SIGMA MEB-5500A EVOKED RESPONSE & EMG MEASURING SYSTEM (K950208)Nihon Kohden America, Inc.1995-05-10
VACUUM SURGE SUPRESSER (K950600)Surgin Surgical Instrumentation, Inc.1995-05-10
JPI AUTOMATIC X-RAY FILM PROCESSOR (K950043)Jpi Healthcare Co, Ltd.1995-05-10
KARL STORZ ENDOSCOPES, TELESCOPE HOLDERS (K951535)KARL STORZ Endoscopy-America, Inc.1995-05-09
GENTAL PULSE (K950238)Parkell, Inc.1995-05-09
DYNAREX GAUZE SPONGE (K951660)Dynarex Corp.1995-05-09
IMPLANTABLE STAPLE (K950562)United States Surgical, A Division of Tyco Healthc1995-05-09
SUGICAL DYNAMICS ENDOSCOPY IRRIGATION PUMP, CATALOG #3-4000 (K950495)Surgical Dynamics, Inc.1995-05-09
1.2MM DISPOSABLE NEUROVIEW PREFORMED ENDOSCOPE (K950705)Neuro Navigational Corp.1995-05-09
FMS ARTHRO-CUTTER (K951701)Future Medical Systems, Inc.1995-05-09
MC ACCLAIM Q6000 BED (K951161)Janco Consulting Services1995-05-09
TROCAR SUPRAPUBIC, NON-DISPOSABLE TROCAR, DISPOSABLE (K950959)Miller Instrument, Inc.1995-05-09
KARL STORZ ENT NEEDLES, TONSIL SYRINGES & NEEDLES (K951395)KARL STORZ Endoscopy-America, Inc.1995-05-09
M. E. R. SURGICAL CO. OMIN INSTRUMENT SYSTEM (K951424)M.E.R. Surgical Co.1995-05-09
CORDIS CSF RESERVOIR (K950315)Cordis Corp.1995-05-09
NEUROSCREEN SOFTWARE FOR USE WITH THE NEUROSIGN 100 NERVE MONITOR (K951641)The Magstim Company , Ltd.1995-05-09
LSU 2000 PORTABLE SUCTION UNIT (K950698)Laerdal Medical Corp.1995-05-09
ARROW KINK RESISTANT FLEXI-CATH INTRA-AORTIC BALLOON (K945230)Arrow Intl., Inc.1995-05-09
BIO-APATITE 6140 HA PARTICLES (K950567)Bio-Interfaces, Inc.1995-05-09
BENCHMARK SERIES ARTHROSCCOPIC INSTRUMENTS (K946151)Depuy, Inc.1995-05-09
SCHIOTZ TONOMETER SPEC. 5 STRAIGHT, INCLINED, 3INCLINED SCALE (K945541)Rudolf Riester GmbH & Co. KG1995-05-08
WAHL FRESH FACE (K944909)Wahl Clipper Corp.1995-05-08
AURAFLEX PROGESTERONE 150TEST PACK (K951630)Organon Teknika Corp.1995-05-08
ATRAUMAX SURGICAL CLAMP (K950492)Applied Medical Resources1995-05-08
CEDIA DAU AMPHETAMINES ASSAY (K951154)Microgenics Corp.1995-05-08
DMA UNSATURATED IRON BINDING CAPACITY PROCEDURE (K946354)Data Medical Associates, Inc.1995-05-08
SYNCHON CX DELTA CLIN SYST (CX4, CX5, CX7 DELTA) (K950958)Beckman Instruments, Inc.1995-05-08
GLUCOSE (HK) REAGENT (PROCEDURE NO.16) (K945908)Sigma Diagnostics, Inc.1995-05-08
OSTEOMARK(R) (K945946)Ostex Intl., Inc.1995-05-08
ARTHROGRAM TRAY (K950683)Surgical Technologies, Inc.1995-05-06
VSP (VARIABLE SCREW PLACEMENT) (K944736)Acromed Corp.1995-05-05
H292 (K942820)Bartels, Inc.1995-05-05
ACUTRAK PLUS FIXATION SYSTEM (K944330)Acu Med, Inc.1995-05-05
CANNUAL AND TROCAR, SUPERPUBIC (K950457)Core Dynamics, Inc.1995-05-05
AMBU PORTABLE SUCTION UNIT (K932031)Ambu, Inc.1995-05-05
SPECTRUM CURING LIGHT POLYMERIZATION UNIT (K951425)Dentsply Intl.1995-05-05
OPTICLONE CD3/CD4 MONOCLONAL ANTIBODIES (K950626)Immunotech Corp.1995-05-05
VARIAN MULTILEAF COLLIMATOR, RELEASE 4.0 (K926449)Varian Assoc., Inc.1995-05-05
TETRAD MODEL 6F, END-VIEWING, ENDOCAVITY PROBE, 4.5/8.5 MHZ, CA (K945318)Tetra Corp.1995-05-05
B-L RED(TM) DISCS (K950346)Oxis Intl., Inc.1995-05-05
VACUTAINER BRAND SAFETY-LOK NEEDLE HOLDER (K950432)Bd Becton Dickinson Vacutainer Systems Preanalytic1995-05-05
KARL STORZ TELESCOPE BRIDGES AND INSERTS, ADAPTERS (K945685)KARL STORZ Endoscopy-America, Inc.1995-05-05
INSTASPOT (K942504)Fidelity Medical, Inc.1995-05-05
INTEGRAL OMNILOC DENTAL IMPLANT WITH INTERFACE RING (K941608)Calcitek, Inc.1995-05-05
CAPITOL URINE DRUG SCREEN COLLECTION KIT (K951122)Harry A. Schlakman1995-05-05
THE GRIESHABER AXIAL CUTTER (K950056)Grieshaber & Co.1995-05-05
DCA 2000 SYSTEM FOR HEMOGLOBIN A1C (K951361)Heraeus Kulzer, Inc.1995-05-05
SLT MULTIDIMENSIONAL CONTACT LASER SYSTEM FAMILY (K931490)Surgical Laser Technologies, Inc.1995-05-05
MINIBONEPLATE SYSTEM (K951392)Ace Surgical Supply Co., Inc.1995-05-05
AQUALARM MOISTURE SENSOR MODEL P85000 (K946057)Pegasus Research Corp.1995-05-05
KIS-V PRE-ANGULATED AND WIDE BODY ABUTMENTS (K950893)The Implant Center of the Palm Beaches1995-05-05
CMI VELVET TOUCH VACUUM EXTRACTOR (K942725)Columbia Medical & Surgical, Inc.1995-05-05
CONSENSUS(TM) ORTHOPEDIC DRILL BIT (K950013)U.S. Medical Products, Inc.1995-05-05
SMALL FRAGMENT PLATES AND SCREWS (K951302)Medpac1995-05-05
EBNA IGG ELISA TEST SYSTEM (K932742)Zeus Scientific, Inc.1995-05-05
CIBA CORNING ACS CORTISOL IMMUNOASSAY (K945367)Ciba Corning Diagnostics Corp.1995-05-05
NEEDLE ELCTRODE (K944265)Unimed Surgical Products, Inc.1995-05-05
THE ULTRA (K935755)Medical Device Systems, Inc.1995-05-05
PHILIPS GALLILEO AUTOMATIC COLLIMATOR (OR BEAM LIMITING DEVICE) (K951372)Philips Medical Systems, Inc.1995-05-04
TETRAD MODEL BS18, ENDOSURGICAL NEEDLE GUIDE ATTACHMENT (K945319)Tetra Corp.1995-05-04
DIGITRACE SLEEP COMPUTER, SLEEPPAC, HOME SLEEP SYSTEM (K944833)New England Medical Monitoring Co.1995-05-04
VISIONS 2.9F ULTRASONIC IMAGING CATHETER (MODEL 84300) (K944004)Endosonics Corp.1995-05-04
LARGE TIP (4MM) DIAGNOSTIC-ELECTROHYSIOLOGY CATHETERS (K951744)Boston Scientific Corp1995-05-04
CCD ENDOCAM 5501 (K950502)Richard Wolf Medical Instruments Corp.1995-05-04
EXTRA PROTECTION POLYURETHANE CONDOM (K922688)Apex Medical Technologies, Inc.1995-05-04
KENEX INJECTOR HEAD SUPPORT (AS EXHIBIT 2) (K951005)Kenex , Ltd.1995-05-04
SYSTEM, IMAGE PROCESSING (K943156)Image Technology, Inc.1995-05-04
CVD BULLETT HI-FLO INFUSION CATHETER (K951503)Cardiovascular Dynamics, Inc.1995-05-04
VAGINAL CONTINENCE DEVICE (K930618)Johnson & Johnson Medical, Inc.1995-05-04
IMAGING TABLE (K951146)Septa Corp.1995-05-04
BLADDER NECK SUPPORT PROTHESIS FITTING KIT (K933654)Johnson & Johnson Medical, Inc.1995-05-04
ECHOMARK(R) ELECTROPHYSIOLOGY CATHETER (K933417)Echocath, Inc.1995-05-04
WALLACH LEAP 100 ELECTRO SURGERY SYSTEM (K921791)Wallach Surgical Devices, Inc.1995-05-04
BODY POSITION INDICATOR, MODEL BPI1 (K940013)Pro-Tech, Inc.1995-05-04
BCM 400CP (K946378)B C Medical , Ltd.1995-05-04
FILTRYZER (K940910)Toray Industries (America), Inc.1995-05-04
LOSSLESS TELERADIOLOGY OPTION FOR USE WITH IES, IMAGE ENHANCEMENT SYSTEM (K950431)Open Mri, Inc.1995-05-04
OTOSCOPE A-34 (K950788)Neitz Instruments Company, Ltd.1995-05-03
PREVIEW TELEIMAGING SYSTEM (K950699)Regulatory Management Services1995-05-03
PACETRAK (K943123)Universal Medical, Inc.1995-05-03
ENDOSCOPIC ACCESSORY (K945191)Un-I-Med, Inc.1995-05-03
HEARTRAK (K943124)Universal Medical, Inc.1995-05-03
BAXTER BIOSTAT 1000 UREA MONITOR (K925581)Baxter Healthcare Corp1995-05-03
STA-PUT NON-MAGNETIC INSTRUMENT DRAPE CATALOG #100-187-00 (16X20), 100-186-00 (16X10), 100-183-00 W/DEXTER WRAP (K950830)Avail-Southwest Division1995-05-03
OXYCHEK OXYGEN ANALYZER (K942593)Nidek Medical Products, Inc.1995-05-03
MIST ENDOSCOPIC CANNULAS (K951481)Mist, Inc.1995-05-03
DRISTAR URINARY INCONTINENCE MANAGEMENT SYSTEM (K950784)Advanced Bioresearch Assoc.1995-05-03
DEPUY COMPRESSION HIP SCREW SYSTEM (K946156)Depuy, Inc.1995-05-03
OLYMPUS FD-5 HOT BIOPSY FORCEPS (K951445)Olympus America, Inc.1995-05-03
AMS 3000M (K936009)Acutronic Medical Systems AG1995-05-03
THE PILOT AUDIOMETER (K951527)American Electromedics Corp.1995-05-03
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