Atlas FDA

1994

5,762 FDA 510(k) clearances · Clearance year

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RecordFirmDate
COBAS(R)-FP REAGENT FOR PROCAINAMIDE/CALIBRATOR (K942847)Roche Diagnostic Systems, Inc.1994-12-02
ANTI DS-DNA (K943291)Sigma Diagnostics, Inc.1994-12-02
KTP/532, KTP/YAG AND KTP/YAG XP (K931445)Laser Surgical Systems1994-12-02
BIOSITE DIAGNOSTICS - TRIAGE PANEL FOR DRUGS OF ABUSE PLUS TRICYCLIC ANTIDEPRESSANTS (K934340)Biosite Incorporated1994-12-02
PHLEBOTOMY UNIT SHARPS A GATOR (K944114)Devon Industries, Inc.1994-12-02
COOK UROLOGICAL LAPAROSCOPIC TROCAR CLEANER (K944303)Cook Urological, Inc.1994-12-02
APTT-ES (K935169)Helena Laboratories1994-12-02
LINICAL PROTEIN VI CALIBRATION VERIFIERS LEVELS A-E (K944513)International Enzymes, Inc.1994-12-02
URIC ACID QVET (K943002)Prisma Systems1994-12-02
LAPAROVIEW (K931065)Northgate Technologies, Inc.1994-11-30
KULTSURE STARSWAB(M240), MODIFICATION (K943499)Ncs Diagnostics, Inc.1994-11-30
OKTAS STEREO VIEWING SYSTEM (K944254)Oktas1994-11-30
SURGICAL CUTTING BURS (K943540)Stryker Corp.1994-11-30
DOCUMENT R AMMONIA/ETHANOL CONTROL (K944361)Casco Standards1994-11-30
MILL-ROSE HARRELL BRONCHIAL BRUSH (K944649)Mill-Rose Laboratory1994-11-30
DELUXE MAGMAG BREAST PUMP (K936309)Pigeon Corp.1994-11-30
FIXODENT, FIXODENT FRESH, FASTEETH AND EXTRA HOLD FASTEETH DENTURE ADHESIVCES (K945200)Procter & Gamble Co.1994-11-30
OLYMPUS PF-8P OES PANCREATO FIBERSCOPE AND ACCESSORIES (K942338)Olympus Corp.1994-11-30
SCHNEIDER PINK POWER SOFTIP GUIDNIG CATHETER (K943622)Boston Scientific Scimed, Inc.1994-11-30
PROCHEM CHEMISTRY ANALYZER (K944028)Prisma Systems1994-11-30
ORION ALL SILICONE FOLEY CATHETER TEMPERATURE PROBE (K944381)Regulatory & Marketing Services, Inc.1994-11-30
MIDMARK M-11 ULTRACLAVE STEAM STERILIZER (K936181)Midmark Corp.1994-11-30
ARROW PERCUTANEOUS SHEATH INTRODUCER KIT AK-07903 (K940079)Arrow Intl., Inc.1994-11-30
COMFIT EXAMINATION GLOVES, POWDER FREE, HYPOALLERGENIC (K942947)Wembley Rubber Products (M) Sdn Bhd1994-11-30
INSTRUMENT,FILLING,PLASTIC,DENTAL (K945077)Worldwide Dental, Inc.1994-11-30
DEVMED DOUBLE-BALLOON UROLOGICAL CATHETER (K941488)Medical Technology Development Corp.1994-11-30
PERFECTA TOTAL HIP SYSTEM COATED COCR FEMORAL STEM (K930771)Orthomet, Inc.1994-11-30
CX OPIATE REAGENT FOR SYNCHRON CX SYSTEMS (K944606)Beckman-Diagnostic Systems Group1994-11-30
DISPOSABLE BACTERIAL BREATHNG FILTER (K915750)Hospitak, Inc.1994-11-30
LATEX EXAMINATION GLOVES (K943707)Arista Latindo Industrial Ltd. P.T1994-11-30
ORION FOLEY CATHETER (K944380)Regulatory & Marketing Services, Inc.1994-11-30
CX(TM) COCAINE METABOLITE(COCM) REAGENT/SYNCHRON CX SYS (K944087)Beckman Instruments, Inc.1994-11-30
VARIOUS STETHOSCOPES (K944337)Rud Riester GmbH & CO KG1994-11-30
MODEL E278OR-ASP SERIES RETRACTABLE (K944244)Valleylab, Inc.1994-11-30
KULTSURE STARSWAB (M210), MODIFICATION (K943498)Ncs Diagnostics, Inc.1994-11-30
PULPDENT CALCIUM HYDROXIDE PREPARATIONS (K944945)Pulpdent Corp.1994-11-30
ORION ALL SILICONE ELASTOMER COATED CATHETER (K944376)Regulatory & Marketing Services, Inc.1994-11-30
ARBO MONITRING SAFETY CABLE & LEAD WIRE SYSTEMS/ARBO UNSHEILDED SAFETY CABLE & LEAD SYSTEM (K940302)Arbo Medical, Inc.1994-11-30
ACOUSTIC RECORDER (K943726)Technology Applications Assoc., Inc.1994-11-30
URO - ELITE TABLE ACCESSORIES (K944987)Philips Medical Systems (Cleveland), Inc.1994-11-30
REUSABLE MENSTRUAL PAD (K924502)Keema and Co.1994-11-30
DENAR ACCUCEPH CEPHALOMETER IMAGING SYSTEM (K944162)Teledyne Water Pik1994-11-29
MICROSIL (K945255)Microsonic, Inc.1994-11-29
MINIMUS I; MINIMUS III, SANAPHON (K942649)Rud Riester GmbH & CO KG1994-11-29
PRIMA, INC. GAS SAMPLING LINES AND CONNECTORS (K944535)Prima, Inc.1994-11-29
WILSON-COOK BALLOON INFLATION DEVICE (K933845)Wilson-Cook Medical, Inc.1994-11-29
MEDRAD COUNTERPOISE SYSTEM (K944983)Medrad, Inc.1994-11-29
ADVANCE ANALYSIS SOFTWARE (K941223)General Electric Co.1994-11-29
PRIMA, INC. CONNECTORS AND AIRWAY EXTENSIONS (K944534)Prima, Inc.1994-11-29
HEAD AND NECK COIL FOR THE GYREX 2T-DLX (K943320)Elscint, Inc.1994-11-29
SAFELINE SYSTEM TURN LOCK CANNULA (K941244)Mcgaw, Inc.1994-11-29
METAL-LINED TRANSCEND CERAMIC BRACKET (K944286)Unitek Corp.1994-11-29
FLEXIBLE LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER (K944790)Applied Medical Resources1994-11-29
ABG NEEDLE PROTECTION (K945485)Devon Industries, Inc.1994-11-29
GAMGRO ENGSTROM Y FILTER WITH EDITH FLEX (1500 F), EDIT 500, 1000, 2600 AND Y FILTER PACKAGED ALONE (K945543)Intersect Medical Products, Inc.1994-11-29
LIFE (K944416)Sybron Dental Specialties, Inc.1994-11-29
HI-Q HAND INSTRUMENTS- UROLOGY (K944201)Olympus America, Inc.1994-11-29
PRIMA, INC. ADULT ANESTHESIA CIRCUIT (K944533)Prima, Inc.1994-11-29
BLOOD PRESSURE METER MODEL NO. BPM888 (K941490)Integrated Display Technology, Ltd.1994-11-29
KERLIX ZINC SALINE DRESSING (K944468)Kendall Healthcare Products Co. Div.Of Tyco Health1994-11-29
CARRASYN FDG (K944427)Carrington Laboratories, Inc.1994-11-29
HUMAN NEWBORN FORESKIN CELL CULTURE (K943887)Neogenex1994-11-28
RD CULTURE CELL (K943891)Neogenex1994-11-28
CALIBRATOR (K943012)Prisma Systems1994-11-28
V-MAX OPTIONS (K943447)Philips Medical Systems (Cleveland), Inc.1994-11-28
PRIMARY RABBIT KIDNEY CELL CULTURE (K943885)Neogenex1994-11-28
COIL POSITIONER SET (K940189)Cook, Inc.1994-11-28
POWER RECLINER (K944423)Sunrise Medical, Inc.1994-11-28
SQUEEZE PLAY (K943730)Conair Corp.1994-11-28
TRUE/FLEX INTRAMEDULLARY ROD END-CAP (K944501)Applied Osteo Systems, Inc.1994-11-28
NORELCO CLEAN AIR SYSTEM (K943238)Philips Electronic North America Corp. (Pena)1994-11-28
VERO CELL CULTURE (K943889)Neogenex1994-11-28
PORTA-RESP MONITOR (K943146)S & M Instrument Co.1994-11-28
POSITIVE AIRWAY PRESSURE SYSTEM (K933184)Innovative Medical Systems, Inc.1994-11-28
MONOGARD FACE SHIELD (K943809)White Knight Healthcare1994-11-28
SERUM/URINE APPLI ILAB(TM) CLINICAL CHEMISTRY SYSTEM (K943595)Instrumentation Laboratory CO1994-11-28
P2 NITRILE EXAM GLOVES (K944514)Biosafety Systems, Inc.1994-11-28
ARBO VS MONITOR CABLE & LEADWIRE SYSTEM ARBO SHIELDED SAFETY CABLE & LEAD WIRE (K940322)Arbo Medical, Inc.1994-11-28
PRIMARY MONKEY KIDNEY CELL CULTURE (K943884)Neogenex1994-11-28
PIONEER LABORATORIES CABLE SCREW (K941866)Pioneer Surgical Technology1994-11-28
VIRASTAT(R) FITC-LABEL ANTI-PARAINFLU 1,2&3 MONO ANT (K933575)Symex Corp.1994-11-28
AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR (K942336)Integrated Display Technology, Ltd.1994-11-28
ORIGIN TACKER SYSTEM (K944415)Origin Medsystems, Inc.1994-11-28
ACE CEDIA CORTISOL ASSAY (K943427)Schiapparelli Biosystems, Inc.1994-11-28
CHEMOTHERAPY SHARPS DISPOSAL CONTAINERS (K943722)Baxter Healthcare Corp1994-11-28
ZIRCONIA CERAMIC FEMORAL HEAD (K935921)Smith & Nephew Richards, Inc.1994-11-28
WI38 CELL CULTURE (K943890)Neogenex1994-11-28
DERMAVBLADE(TM) (K945430)Hasting'S Biomedical Corp.1994-11-28
REMEL RIM STREPTOCOCCUS GROUPING LATEX AGGLUTINATION TEST (K942093)Medical Diagnostic Technologies, Inc.1994-11-28
ENDOCARE PROLASE I ADVANCED LASER DELIVERY SYSTEM (K945054)Cytocare, Inc.1994-11-28
MDCK CELL CULTURE (K943888)Neogenex1994-11-28
TROCAR ( ACCESORY) (K945457)United States Surgical, A Division of Tyco Healthc1994-11-28
VACUTAINER BRAND NEEDLE DISPOSAL CONTAINER (K943138)Med-Safe Systems, Inc.1994-11-28
GAMMA LOCKING NAIL - LONG LENGTH (K944883)Howmedica Corp.1994-11-28
NORELCO CLEAN AIR SYSTEM CAS900 (K944927)Norelco Consumer Products Co.1994-11-28
SAUNDERS ELECTRONIC INCLINOMETER (K943898)The Saunders Group1994-11-28
STORZ PHACO AND FRAG HANDPIECES (K935926)Storz Instrument Co.1994-11-28
LATERALASE, MODIFIED (K944204)Trimedyne, Inc.1994-11-28
STIEGMANN-GOFF ENDOSCOPIC LIGATOR (K940661)C.R. Bard, Inc.1994-11-28
SKIN NEUVEAU SCAR TREATMENT (K942339)Puritas Health Care, Inc.1994-11-28
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Every clearance here is in the API, with alerts when new ones post.