Atlas FDA

1989

5,030 FDA 510(k) clearances · Clearance year

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RecordFirmDate
PATIENT EXAMINATION GLOVES (LATEX) (K891639)Tak Ent., Inc.1989-04-13
PATIENT EXAMINATION GLOVES (LATEX) (K891632)Rank Rubber Industries Sdn Bhd1989-04-13
PATIENT EXAMINATION GLOVES (LATEX) (K891264)Safeskin Corp.1989-04-13
TISSUE FORCEPS, VARIOUS TYPES (K891896)Zinnanti Surgical Instruments, Inc.1989-04-12
C-86 GOLD BASE DENTAL ALLOY (K891519)Macdonald Metals and Ceramics1989-04-12
M-60 GOLD BASE DENTAL ALLOY (K891527)Macdonald Metals and Ceramics1989-04-12
SURGICAL LOUPES (K891895)Zinnanti Surgical Instruments, Inc.1989-04-12
PATIENT EXAMINATION GLOVES (LATEX) (K891877)W.A. Rubbermate Co. C/O Orient Intl. Trading, Inc.1989-04-12
OLIVECORONA SCISSORS (K891889)Zinnanti Surgical Instruments, Inc.1989-04-12
SHARPLAN MODEL 1050 SEALED-OFF CO2 SURGICAL LASER (K890287)Sharplan Lasers, Inc.1989-04-12
REVISED OHMEDA MODULUS II ANESTHESIA GAS MACHINE (K890410)Ohmeda Medical1989-04-12
MODIFIED STOCKERT-SHILEY CAPS MULTI. ROLLER PUMP (K890904)Shiley, Inc.1989-04-12
M-65 GOLD BASE DENTAL ALLOY (K891528)Macdonald Metals and Ceramics1989-04-12
M-4 GOLD BASE DENTAL ALLOY (K891522)Macdonald Metals and Ceramics1989-04-12
M-46 GOLD BASE DENTAL ALLOY (K891525)Macdonald Metals and Ceramics1989-04-12
EBV EARLY ANTIGEN (R+D) (K884829)Hillcrest Biologicals1989-04-12
DENTAL BIB (K891053)Dispomed, Inc.1989-04-12
SENSODYNE SEALANT DENTIN CONDITIONING SYSTEM (K884533)Block Drug Company, Inc.1989-04-12
D-SCOPE III (K884661)Medx, Inc.1989-04-12
C-63 GOLD BAE DENTAL ALLOY (K891517)Macdonald Metals and Ceramics1989-04-12
SURGICAL CONE MASK (K891056)Dispomed, Inc.1989-04-12
C. ALBICANS SCREEN (K891476)Carr-Scarborough Microbiologicals, Inc.1989-04-12
SCISSORS, VARIOUS TYPES (K891886)Zinnanti Surgical Instruments, Inc.1989-04-12
M-1 GOLD BASE DENTAL ALLOY (K891521)Macdonald Metals and Ceramics1989-04-12
M-W SILVER PALLADIUM BASE DENTAL ALLOY (K891529)Macdonald Metals and Ceramics1989-04-12
TITAN GEL IFE FREE KAPPA/LAMBA LIGHT CHAIN ANTISER (K891683)Helena Laboratories1989-04-12
ELEVATORS, VARIOUS TYPES (K891899)Zinnanti Surgical Instruments, Inc.1989-04-12
M-74 GOLD BASE DENTAL ALLOY (K891533)Macdonald Metals and Ceramics1989-04-12
ELEVATORS-COTTLE,MCKENTY,GOLDMAN,JOSEPH,CONVERSE (K891894)Zinnanti Surgical Instruments, Inc.1989-04-12
OSTEOTOMES, VARIOUS TYPES (K891887)Zinnanti Surgical Instruments, Inc.1989-04-12
MODEL 611101 CONTRAST INJECTION DEVICE (K890898)Medtronic Versaflex, Inc.1989-04-12
M-40 GOLD BASE DENTAL ALLOY (K891524)Macdonald Metals and Ceramics1989-04-12
SURGICAL FACE MASK-EAR LOOP (K891051)Dispomed, Inc.1989-04-12
P-C PALLADIUM BASE DENTAL ALLOY (K891535)Macdonald Metals and Ceramics1989-04-12
M-50 GOLD BASE DENTAL ALLOY (K891531)Macdonald Metals and Ceramics1989-04-12
M-75 GOLD BASE DENTAL ALLOY (K891534)Macdonald Metals and Ceramics1989-04-12
ROLLET RETRACTOR (K891892)Zinnanti Surgical Instruments, Inc.1989-04-12
CURRETTES - PIFFARD, WOLF, VIDAL-SCRAPER (K891888)Zinnanti Surgical Instruments, Inc.1989-04-12
DENTAL GOWN (K891058)Dispomed, Inc.1989-04-12
PATIENT EXAMINATION GLOVE (LATEX) (K891868)Bber Sound Rubber Industrial Co., Ltd.1989-04-12
OCULAR CONNECTION MACHINE(TM) (K890133)Innovision Medical, Inc.1989-04-12
URIC ACID KIT, CODES 4825400 AND 4825050 (K890319)American Research Products Co.1989-04-12
M-20 GOLD BASE DENTAL ALLOY (K891523)Macdonald Metals and Ceramics1989-04-12
GOUGES, ALEXANDER, BISHOP, LUCAS (K891901)Zinnanti Surgical Instruments, Inc.1989-04-12
C-5 PALLADIUM BASE DENTAL ALLOY (K891514)Macdonald Metals and Ceramics1989-04-12
CHISELS- FREER, LUCAS, ALEXANDER, BISHOP (K891902)Zinnanti Surgical Instruments, Inc.1989-04-12
C-87 GOLD BASE DENTAL ALLOY (K891520)Macdonald Metals and Ceramics1989-04-12
SKIN HOOKS, VARIOUS TYPES (K891898)Zinnanti Surgical Instruments, Inc.1989-04-12
C-76 GOLD BASE DENTAL ALLOY (K891518)Macdonald Metals and Ceramics1989-04-12
M-70 GOLD BASE DENTAL ALLOY (K891532)Macdonald Metals and Ceramics1989-04-12
REPOSITIONABLE BITEWING X-RAY FILM HOLDER KIT (K891186)Benn Research , Ltd.1989-04-12
SPLASH GUARD GOGGLE (K891052)Dispomed, Inc.1989-04-12
IMMUNOCOMB(TM) TOXOPLASMA IGG ANTIBODY TEST KIT (K885344)Orgenics, Ltd.1989-04-12
CMV-CUBE(TM) (K884842)Difco Laboratories, Inc.1989-04-11
ACU-CURETTE (K891334)Acuderm, Inc.1989-04-11
MODIFIED VAS-CATH CATHETER REPAIR KIT (K890099)Vas-Cath, Inc.1989-04-11
PATIENT EXAMINATION GLOVES (VINYL) (K891860)Cypress Medical Products, Ltd.1989-04-11
MANAN BONE MARROW BIOPSY NEEDLE (K890925)Manan Medical Products, Inc.1989-04-11
EAGLE VISION-FREEMAN(TM) PUNCTAL VALVE (K890920)Eagle Vision, Inc.1989-04-11
VINYL EXAM GLOVES (MFG. PRECIOUS MOUNTAIN ENT.) (K891567)Neo-Sigma, Inc.1989-04-11
VINYL EXAM GLOVES (MFG. AM GLOVES CO. LTD.) (K891566)Neo-Sigma, Inc.1989-04-11
QBC(R) CENTRIFUGAL HEMATOLOGY CONTR/MULTI MODIFIED (K891907)R&D Systems, Inc.1989-04-11
VINYL EXAM GLOVES (MFG. JM GLOVES CO. LTD.) (K891568)Neo-Sigma, Inc.1989-04-11
RUBBER LATEX PATIENT EXAMINATION GLOVES (K891866)Amsia Intl., Inc.1989-04-11
SKIN ANGEL BRAND (PATIENT EXAM GLOVES - LATEX) (K891854)Unidus Corp.1989-04-11
MICROSCOPE KNOB COVER, STERILE, DISPOSABLE (K891001)Prescott'S, Inc.1989-04-11
PATIENT EXAMINATION GLOVE (K891128)Jensen Union Ent. Co., Ltd.1989-04-11
PATIENT EXAMINATION GLOVES (LATEX) (K891885)Alfaseal Sdn. Bhd.1989-04-11
AMMEX LATEX EXAMINATION GLOVES (K891850)Ammex Corp.1989-04-11
PATIENT EXAMINATION GLOVES (LATEX) (K891883)China National Machinery & Equipment Import & Expo1989-04-11
DADE THROMBOPLASTIN IS (K891169)Baxter Healthcare Corp1989-04-10
HDL CHOLESTEROL REAGENT (K891117)Pointe Scientific, Inc.,1989-04-10
BIOTROL CHEMISTRY URINE CONTROL (K891286)Biotrol, USA, Inc.1989-04-10
EDL NORMAL COAGULATION CONTROL (K891179)Elite Diagnostic , Ltd.1989-04-10
SHAPE-ACTIO METAL TOXICOLOGY CONTROL (K890721)Actio, Inc.1989-04-10
HTS 220 CARDIAC MONITOR (K884524)Life Sensing Instrument Company, Inc.1989-04-10
PRE-MOISTENED CLEANSING PAD (K890514)Bausch & Lomb, Inc.1989-04-10
ABBOTT ALT-ACTIVATED (LIQUID, LIST #01A55) (K890698)Abbott Laboratories1989-04-10
MODIFIED DDI SEROCARD HERPES IGG TEST KIT (K884246)Disease Detection International, Inc.1989-04-10
HI CHEM CALCIUM REAGENT #88808 (K890584)Hichem Diagnostics1989-04-10
MODIFIED DDI SEROCARD CMV IGG TEST KIT (K884248)Disease Detection International, Inc.1989-04-10
BORRELIA BURGDORFERI IGG ANTIBODY TEST SYSTEM (K885293)Medical Diagnostic Technologies, Inc.1989-04-10
MODIFIED DDI SEROCARD RUBELLA IGG TEST KIT (K884247)Disease Detection International, Inc.1989-04-10
EDL ABNORMAL COAGULATION CONTROL (K891175)Elite Diagnostic , Ltd.1989-04-10
MODIFIED DDI SEROCARD TOXOPLASMA IGG TEST KIT (K884249)Disease Detection International, Inc.1989-04-10
BORRELIA BURGDORFERI IGM ANTIBODY TEST SYSTEM (K885294)Medical Diagnostic Technologies, Inc.1989-04-10
PHRENIC NERVE PAD & NERVE PAD W/1/4 PERCARDIAL (K890707)Dlp, Inc.1989-04-10
BORRELIA BURGDORFERI POLYVALENT IGG/IGM ANTIBODY (K885290)Medical Diagnostic Technologies, Inc.1989-04-10
EXTEND INTENDED USE FOR ENZYME RINSE CONCENTRATE (K890990)Hichem Diagnostics1989-04-10
VENTREX COATED TUBE T3 UPTAKE (K891068)Ventrex Laboratories, Inc.1989-04-10
PM830 ELECTRIC MASSAGER (K891394)Back IN Action, Inc.1989-04-10
PLEUR-EVAC(R) A-8020--INFANT CHEST DRAINAGE SYSTEM (K890129)Deknatel, Inc.1989-04-10
HI-RIDER WHEELCHAIR (K890695)Retec USA, Inc.1989-04-10
CRACK-IT CANNABINOID SCREEN (K874390)Sakers, Inc.1989-04-10
MODIFIED SUTURE DISP. ENDOSCOPIC SURGICAL CLIP APP (K890941)United States Surgical, A Division of Tyco Healthc1989-04-07
C-52 GOLD BASE DENTAL ALLOY (K891515)Macdonald Metals and Ceramics1989-04-07
PRECEPT MICRO-GARD LASER MASK (K891409)Mars White Knight1989-04-07
AIDE-A-PATIENT (NURSING HOME BED) (K890293)Morton Metalcraft Co.1989-04-07
M-56 GOLD BASE DENTAL ALLOY (K891526)Macdonald Metals and Ceramics1989-04-07
SODIUM BICARBONATE, U.S.P. (K891159)Williams Medical Co.1989-04-07
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Every clearance here is in the API, with alerts when new ones post.