Atlas FDA

1988

4,299 FDA 510(k) clearances · Clearance year

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RecordFirmDate
NSN #6515-00-690-3209 DEBAKEY TISSUE FORCEPS (K875319)I-Tech Industries, Inc.1988-01-22
DISPOSABLE SURGICAL FACE MASK (K875172)Irema USA , Ltd.1988-01-22
KLEENSPEC DISPOSABLE FACE SHIELD, MODEL 57001 (K875194)Welch Allyn, Inc.1988-01-22
SUCTION RETRACTOR (K875289)T. Korossurgical Instruments Corp.1988-01-22
MODEL 5050 SURGILASER FOR NEUROSURGERY USE (K871933)Lasermatic, Inc.1988-01-22
INTERFERENTIAL CURRENT UNIT (K874119)Compustim Electronics1988-01-22
ADEL MODEL 2100 BIRTHING BED (K874610)Adel Medical , Ltd.1988-01-21
PYRIDOXAL-5-PHOSPHATE TABLETS (K874835)Boehringer Mannheim Corp.1988-01-21
KODAK EKTACHEM DT SLIDES (PHOS) (K874577)Eastman Kodak Company1988-01-21
A-GENT TRIGLLYCERIDES GPO (K874187)Abbott Laboratories1988-01-21
CAPILLARY COLUMNS FOR GAS CHROMATOGRAPHY (K874824)Supelco, Inc.1988-01-21
EASY-TEST ALANINE AMINOTRANSFERASE (ALAT) #19017 (K874586)Em Diagnostic Systems, Inc.1988-01-21
WAKO(TM) PRETEST 5A (K873366)Wako Chemicals USA, Inc.1988-01-21
MULTICHEM (R) MAGNESIUM REAGENT (K874595)Simmler, Inc.1988-01-21
TRIGLYERIDES TEST KIT (K874584)Ciba Corning Diagnostics Corp.1988-01-21
RAICHEM(TM) MAGNESIUM REAGENT (K874822)Reagents Applications, Inc.1988-01-21
SHOT-GUN ISOLAT PROCED/MEASUREMENT CK-MB IN SERUM (K874284)Diagnostic Chemicals, Ltd. (Usa)1988-01-21
V-TREND BETA-HCG TEST (K874638)Texas Immunology, Inc.1988-01-21
STRATUS VANCOMYCIN FLUOROMETRIC ENZYME IMMUNOASSAY (K874438)Baxter Healthcare Corp1988-01-21
KODAK EKTACHEM DT SLIDES (MG) (K874576)Eastman Kodak Company1988-01-21
XL-4 PAGODA (CONDOMS) (K874851)Mayer Laboratories1988-01-21
LYPHOCHEK ASSAYED CHEMISTRY CONTROL (HUMAN), I/II (K874280)Bio-Rad1988-01-21
EASY-TEST ASPARTATE AMINOTRANSFERASE (ASAT) #19010 (K874600)Em Diagnostic Systems, Inc.1988-01-21
QUANTIMETRIX URINE DIPSTICK CONTROL (K874890)Quantimetrix Medical Industries1988-01-21
VAN DELLEN BACTERIA FILTER (K873465)Van Dellen, Ltd.1988-01-20
ACROMED CANCELLOUS BONE SCREW (K875053)Buckman Co., Inc.1988-01-20
LASER LAPAROSCOPY SET (K873598)Cuda Products Co.1988-01-20
VITALON MASSAGER (K874843)Nexus Co. , Ltd. C/O Yama Trans Co. , Ltd.1988-01-20
IVY COMMANDER (MODEL 500) (K870820)Ivy Medical, Inc.1988-01-20
ACE INTRA COMPARTMENTAL PRESSURE MONITOR (K873684)Ace Medical Co.1988-01-20
SECURLINE FINE NEEDLE ASPIRATION BIOPSY TRAY (K874665)Precision Dynamics Corp.1988-01-20
AGC UNICOMPARTMENTAL KNEE PROSTHESIS (K873601)Biomet, Inc.1988-01-20
LEE COMPOSITE INLAY SYSTEM (K873123)Lee Pharmaceuticals1988-01-20
STAINLESS STEEL ORTHOPAEDIC CABLE SYSTEM (K875156)Richards Medical Co., Inc.1988-01-20
BIO-FEEDBACK LIMB MONITOR TYPE CODE BL-34-1 (K875103)Shield Computers , Ltd.1988-01-20
SCENTED OR SCENTED DEODORIZED MENSTRUAL PADS (K873457)Procter & Gamble Mfg. Co.1988-01-19
COULTER IMMUNOPREP LEUKOCYTE/Q-PREP IMMUNO WRK STA (K874188)Coulter Electronics, Inc.1988-01-19
SOLCO SILICONE RESUSCITATOR (K874321)Kahn-Tact U.S.A., Inc.1988-01-19
AUTOMATIC VENTILATOR AV2000 (K874656)Life Support Products, Inc.1988-01-19
CONCHA, CAVUM, CANAL, CONCHA-P HEARING AID (K874369)Altamonte Hearing Clinic1988-01-19
UNIVERSAL EXAMINATION TABLE (K874934)Imatron, Inc.1988-01-19
MON-A-THERM'S SKIN TEMPERATURE SENSOR (K875234)Mon-A-Therm, Inc.1988-01-19
TRIAD NUCLEAR IMAGING SYSTEM (K873775)Trionix Research Laboratory, Inc.1988-01-19
BARD BIOPOTENTIAL AMPLIFIER (K874441)C.R. Bard, Inc.1988-01-19
AUDIOTONE MODEL A-90, BEHIND-THE-EAR HEARING AID (K874384)Audiotone, Inc.1988-01-19
CADD-PLUS(TM) MODEL 5400 AMBULATORY INFUSION PUMP (K874649)Pharmacia Deltec, Inc.1988-01-19
PACING LEADS MODEL 3262VU/VB, 3362VU/VB, 3380/3390 (K874743)Pace Medical1988-01-19
THE WOOG ORATEST (K874374)Woog Intl.1988-01-19
UNI-VENT(TM) IMPACT MINUTE VOLUME VENTILATOR (K870861)Impact Instrumentation, Inc.1988-01-19
VARIVIEWER (X-RAY FILM VIEWER) (K875233)Diversified Diagnostic Products, Inc.1988-01-19
MODEL EEG 4400 WITH OPTIONAL ACCESSORIES (K874796)Nihon Kohden America, Inc.1988-01-19
COEUR CONTROL SYRINGE (K874579)Coeur Laboratories, Inc.1988-01-19
TRANSJAW(TM) (K872815)Vitek, Inc.1988-01-19
HERCO SILICONE RESUSCITATOR OR SUN-MED RESUSCITA. (K875077)Herco Products, Inc.1988-01-19
MEMBRANE HUMIDIFIER (K873472)Respiratory Support Products, Inc.1988-01-19
ATTENDS INCONTINENT BRIEF (K873036)Procter & Gamble Mfg. Co.1988-01-19
MODEL 5013 TRANSVENOUS VENTRICULAR PACING LEAD (K874792)Medtronic Vascular1988-01-19
EZ BRUSH & FLOSS (K873317)Ez Products, Ltd.1988-01-19
INFANT INTENSIVE CARE SYSTEM VERTICAL HEIGHT ADJUS (K875270)Air-Shields, Inc.1988-01-19
MINI CROSSER BATTERY POWERED WHEELCHAIR (K873500)Heisteel DK Aps1988-01-19
HUCHEL BODYLINER (K873576)Hans-Juergen Huchel1988-01-19
H-H EXTERNAL VENTRICULAR DRAINAGE COLLECTION BAG (K874508)Holter-Hausner Intl.1988-01-19
ARGYLE CARDIOPLEGIA CANNULA (K874834)Sherwood Medical Co.1988-01-19
CAP-35 AND CAP35 F (K874924)Gish Biomedical, Inc.1988-01-19
OPTEC SUPPLEMENTARY KIT (K874275)Pentron Corp.1988-01-19
IVAC(R) DUAL RATE ADAPTER - MODEL 70090 (K874581)Y1988-01-19
SEPACELL R-500 AND SEPACELL R-500A (K873792)Advocacy International, Ltd.1988-01-19
OTICON HEARING AID MODEL I52 (K874651)Oticon Corp.1988-01-19
BAXTER ACCUPORT(TM) CENTRAL VENOUS CATHETER (K874618)Bentley Laboratories, Inc.1988-01-19
SHIMADZU CATHETERIZATION C-ARM STAND MH-50A (K875157)Shimadzu Precision Instruments, Inc.1988-01-19
ROTATING HEMOSTATIC VALVE (K873971)Target Therapeutics1988-01-19
THERMOVENT 600, 1200, T, 02 (K874597)Portex, Inc.1988-01-19
KODAK KODAFLEX II CASSETTE (K875083)Eastman Kodak Company1988-01-19
ISOKINETIC SYSTEM, TESTING AND EVALUATION (K875235)Orthopedic Systems, Inc.1988-01-19
CPE 2000 CARDIO PULMONARY ERGOMETER (K874925)Medical Graphics Corp.1988-01-19
FLUORO COVER (K873985)Condor Medical1988-01-19
CONDOM (PROPHYLACTIC) (K874135)Pactec, Inc.1988-01-19
ESOPHAGEAL OBTURATOR/TRACHEAL TUBE (K875226)Sheridan Catheter Corp.1988-01-19
MINIOX IV PORTABLE PULSE OXIMETER (K874132)Catalyst Research Corp.1988-01-19
BED ALERT (K872522)Nite Train-R Enterprises, Inc.1988-01-19
SAFETY SHIELD KIT (K873731)Ballard Medical Products1988-01-15
ACE/FISCHER PERCUTANEOUS HALF PINS (K875012)Buckman Co., Inc.1988-01-14
J&J SCALP VEIN INFUSION SETS (K875177)Critikon Company, LLC1988-01-14
MX710 SERIES VASCULAR ACCESS INFUSION SET (K874133)Medex, Inc.1988-01-14
HYPODERMIC NEEDLES, SINGLE LUMEN (K874414)Harbor Medical Devices, Inc.1988-01-14
ULTRA TAN PURPLE PRO (K875190)Ultra Tan Intl. AB1988-01-14
PHARMANET (TM) (K872572)Pharmacia, Inc.1988-01-14
M-LENS (THIRTY DEGREE ENDOSCOPE) (K873795)Opto Vision, Inc.1988-01-14
ACE PERCUTANEOUS 3MM HALF-PINS (K875013)Buckman Co., Inc.1988-01-14
ORTHOMET BONE PLATES (K875086)Orthomet, Inc.1988-01-14
OMNIFLEX NORMALIZED HIP STEM FOR PRESS-FIT FIXAT. (K872768)Osteonics Corp.1988-01-14
DEBRISAN ABSORBENT PAD (K872453)Pharmacia, Inc.1988-01-14
ARTHROSCOPIC RETENTION-MANIPULATION SYSTEM (ARMS) (K873619)Arthropedics, Inc.1988-01-14
TYMPANIC TEMPERATURE SENSOR (K873205)Respiratory Support Products, Inc.1988-01-14
ACE/FISHER PERCUTANEOUS TRANSFIXING PINS (K875022)Buckman Co., Inc.1988-01-14
DYNAFILM (K874478)Ferris Mfg. Corp.1988-01-14
ULTRA TAN PURPLE MINT (K875189)Ultra Tan Intl. AB1988-01-14
MACHIDA AMERICA MODEL AC-5000 AUTOMATIC DISINFECT. (K871712)Machida America, Inc.1988-01-14
MODEL OPO-32 IRRIGATION SLEEVE (K874543)Allergan, Inc.1988-01-14
SIEMENS SONODYNATOR 834, ULTRASOUND/STIMULATION (K872909)Elmed, Inc.1988-01-13
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Every clearance here is in the API, with alerts when new ones post.