Atlas FDA

1989

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

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RecordFirmDate
CONTINUOUS EPIDURAL ANESTHESIA TRAY (K893938)Medsurg Industries, Inc.1989-08-07
VECSEI EXPANDING SCREW (K892925)Howmedica Corp.1989-08-07
CT SYTEC 3000 (K893820)General Electric Co.1989-08-07
LIGHTSCOPE SET (K894557)Optik1989-08-07
MINI LIGHTSCOPE SET, LIGHTSCOPE JR. SET (K894558)Optik1989-08-07
MEDTRONIC MODEL 3530 PERCUTANEOUS EXTENSION (K892884)Medtronic Vascular1989-08-07
VOLUME COMPUTATION SOFTWARE PACKAGE (K890638)Elscint, Inc.1989-08-07
NIDEK MODEL AKC-8000 (K894273)Nidek, Inc.1989-08-07
GAMMAMED 12I (K891131)Mick Radio-Nuclear Instruments, Inc.1989-08-07
STRIP, STERILIZATION INDICATOR; STEAM OR E.O. GAS (K890765)Spsmedical Supply Corp.1989-08-07
LABEL, STERILIZATION INDICATOR; RADIATION (K890764)Spsmedical Supply Corp.1989-08-07
STRIP, STERILIZATION INDICATOR; STEAM (K890759)Spsmedical Supply Corp.1989-08-07
STRIP, STERILIZATION INDICATOR; DRY HEAT (K890761)Spsmedical Supply Corp.1989-08-07
DRY HEAT STERILIZATION INDICATOR TAPE (K890758)Spsmedical Supply Corp.1989-08-07
GERBER PRECIOUS CARE ELECTRIC BREAST PUMP (K891996)Gerber Products Co.1989-08-07
SEALING TAPE, STERILIZATION INDICATOR; STEAM (K890755)Spsmedical Supply Corp.1989-08-07
EASY BREATHER MODEL 100 (K893213)Progressive Productions , Ltd.1989-08-04
PLAYTEX TAMPONS, NON-DEODORANT/DEODORANT (K893725)Playtex Family Products, Inc.1989-08-04
QM300 ALPHA1-ACID GLYCOPROTEIN ANTIBODY PACK (K894538)Kallestad Diag, A Div. of Erbamont, Inc.1989-08-04
NON-STERILE PATIENT EXAMINATION GLOVES (K892772)Care-Pro Industries, Inc.1989-08-04
PURITAN-BENNETT 7200SPI MICROPROCESSOR VENTILATOR (K893043)Puritan Bennett Corp.1989-08-04
PROSTATE SPECIFIC ANTIGEN IMMUNOHISTOCHEMICAL ANTI (K893508)Baxter Healthcare Corp1989-08-04
PROWESS 2000 (K884261)Small Systems Group, Inc.1989-08-04
PHARMASEAL GENETIC AMNIOCENTESIS TRAY (K894031)Baxter Healthcare Corp1989-08-04
SURGICAL DYNAMICS DISCOGRAPHY SYSTEM (K894336)Surgical Dynamics, Inc.1989-08-04
PERSONAL AMPLIFIER RECHARGEABLE MODEL TRIUMPH II (K893432)Electone, Inc.1989-08-04
QUICKPAD (ALCOHOL SWABS) (K892193)Holtsch Co., Inc.1989-08-04
RESOUND CUSTOM IN-THE CANAL HEARING AID PHS-3 (K893927)Resound Corp.1989-08-04
TRT (ACUSON) NEEDLE GUIDE KIT, STERILE (K892068)Amedic USA1989-08-04
IFA SENSIBAC BACITRACIN (K892717)Investigacion Farmaceutica S.A. DE C.V.1989-08-03
EMIT D.A.U. LOW & MEDIUM CALIBRATOR A (K894327)Syva Co.1989-08-03
D88VS WHEELCHAIR POWER SYSTEM (K894346)Damaco1989-08-03
ACS HUMAN PLASMA COAGULATION CONTROL LEVEL III (K894425)Analytical Control Systems, Inc.1989-08-03
JAMES SURGICAL SYSTEM J1000 (K890195)O.R. Specialties, Inc.1989-08-03
OPUS IMMUNOASSAY SYSTEM (K894159)Pb Diagnostic Systems, Inc.1989-08-03
COBAS FARA II CENTRIFUGAL ANALYZER (K893854)Roche Diagnostic Systems, Inc.1989-08-03
IFA SENSIBAC TOBRAMYCIN (K892729)Investigacion Farmaceutica S.A. DE C.V.1989-08-03
HYDRO-SAN COLONIC IRRIGATION SYSTEM (K891585)Specialty Health Products, Inc.1989-08-03
GILSDORF PERCU. ENDO.-PEG & PERCU. FLOURO.-PFG (K891371)Entech, Inc.1989-08-03
ABBOTT ASSET AUTOMATED CLINICAL CHEMISTRY ANALYZER (K893776)Abbott Laboratories1989-08-03
APACERAM OSSICULAR PROSTHESIS (K893134)Asahi Optical Co. C/O Rosati Associates, P.C.1989-08-03
IFA SENSIBAC NITROFURANTOIN (K892715)Investigacion Farmaceutica S.A. DE C.V.1989-08-03
GOOTT MULTIPURPOSE FLEXIBLE RETRACTOR (STERILE) (K893869)Adept-Med Intl., Inc.1989-08-03
PRIMAPORE I.V. (K893900)Smith & Nephew United, Inc.1989-08-03
LATEX EXAMINATION GLOVES (K893264)P.T. Kreasi Bhojwanis1989-08-03
PERCUTANEOUS INTRODUCER (K893658)Medamicus, Inc.1989-08-03
STATUS HCG FLUOROMETRIC ENZYME (K893577)Baxter Healthcare Corp1989-08-03
IMMUNO-WASH AUTOMATED TUBE WASHER (K893810)Ocean Scientific, Inc.1989-08-03
MENTOR CYLINDER PROTECTOR TOOL (INFLATABLE PENILE) (K890402)Mentor Corp.1989-08-03
PATIENT LATEX EXAMINATION GLOVES (K892982)Ataro Industri (Malaysia) Sdn Bhd1989-08-03
PRECIOUS LITE MODEL 4224 (K892940)E & B Technologies, Inc.1989-08-03
IFA SENSIBAC CINOXACIN (K892722)Investigacion Farmaceutica S.A. DE C.V.1989-08-03
RUBELLA ELISA TEST SYSTEM (K891783)Zeus Scientific, Inc.1989-08-03
IFA SENSIBAC ERYTHROMYCIN (K892719)Investigacion Farmaceutica S.A. DE C.V.1989-08-03
BURRON TEFLON-COATED GUIDEWIRE (K884183)Burron Medical, Inc.1989-08-03
SENSOCOR TM R-TEST 24OXL (K894234)Sensocor1989-08-03
GOOTT BALFOUR BLADE (K893871)Adept-Med Intl., Inc.1989-08-03
VAX-T PELVIC TRACTION BELT (K894435)Vat-Tech, Inc.1989-08-03
MODELS HP 43110MC, 43200MC W/CASE & 43200M NO CASE (K893403)Hewlett-Packard Co.1989-08-03
MG II POROUS TOTAL KNEE SYSTEM (K892800)Zimmer, Inc.1989-08-03
IFA SENSIBAC VANCOMYCIN (K892725)Investigacion Farmaceutica S.A. DE C.V.1989-08-03
ABUSCREEN ONTRAK POS. REF. CONTROL FOR MORPHINE (K893856)Roche Diagnostic Systems, Inc.1989-08-03
BEHIND-THE-EAR HEARING AID MODEL 48 AGCI (K892338)Qualitone1989-08-03
SIEMENS SAO2 + PULS OXIMETRY CARTRIDGE (K893470)Siemens Medical Electronics1989-08-03
PATIENT EXAMINATION GLOVES (LATEX) (K891184)Healthcare Gloves Sdn Bhd1989-08-03
IFA SENSIBAC TETRACYCLINE (K892718)Investigacion Farmaceutica S.A. DE C.V.1989-08-03
QBC MALARIA SYSTEM (K891276)Bd Becton Dickinson Vacutainer Systems Preanalytic1989-08-03
PATHODX(TM) CHLAMYDIA DIRECT SPECIMEN (PDCY1) (K893905)Diagnostic Products Corp.1989-08-03
TUFFCARE MEDICAL PRODUCTS WHEELCHAIR (K894422)Tuffman Industries1989-08-03
UNIVERSAL CEMENTED CUP (K894249)Orthopedic Systems, Inc.1989-08-03
IFA SENSIBAC INIPENEM (K892727)Investigacion Farmaceutica S.A. DE C.V.1989-08-03
SERALYZER HDL CHOLESTEROL PROCEDURE USE W/STRIP (K893548)Heraeus Kulzer, Inc.1989-08-03
ABBOTT IMX(TM) D-DIMER (K893961)Abbott Laboratories1989-08-03
LATEX EXAM GLOVES (K892971)P.C. Commercial, Inc.1989-08-03
ABUSCREEN ONTRAK POS. REFERENCE CONTROL FOR THC (K893858)Roche Diagnostic Systems, Inc.1989-08-03
SARNS PRESSURE ADJUSTABLE SAFETY SYSTEM (K893683)3M Company1989-08-03
QUALICHECK 2 (K894110)Radiometer America, Inc.1989-08-03
AMERLEX-MAB FT4 KIT (K894091)Amersham Corp.1989-08-03
INTEGRA(TM) BLOOD GLUCOSE MONITORING SYSTEM (K893404)Apprise, Inc.1989-08-03
ABUSCREEN ONTRAK POS. REF. CONTROL FOR BARBITUATES (K893855)Roche Diagnostic Systems, Inc.1989-08-03
IFA SENSIBAC CHLROAMPHENICOL (K892730)Investigacion Farmaceutica S.A. DE C.V.1989-08-03
ETHICON DISPOSABLE SURGICAL TROCAR (K893715)ETHICON, Inc.1989-08-03
INTRAVASCULAR CATHETER WITH HYDROPHILIC COATING (K891580)Boston Scientific Corp1989-08-03
PATIENT EXAMINATION GLOVES (K892981)Lapoma Gloves Industries Sdn. Bhd.1989-08-03
ABUSCREEN ONTRAK POS. REF. CONTROL FOR COCAINE (K893859)Roche Diagnostic Systems, Inc.1989-08-03
IFA SENSIBAC NEOMYCIN (K892714)Investigacion Farmaceutica S.A. DE C.V.1989-08-03
MICRO-AIRE STERNUM SAW 4800 (K894301)Micro Surgical Instruments Corp.1989-08-03
AMBULATORY INFUSION PUMP (K890862)Medfusion, Inc.1989-08-03
IFA SENSIBAC STREPTOMYCIN (K892724)Investigacion Farmaceutica S.A. DE C.V.1989-08-03
ASC-950 ECG AMPLIFIER (K894161)Astro-Med, Inc.1989-08-03
VENTIPRESS 24 AND 14 PRESSURE VENTILATOR (K893950)Ventipress OY1989-08-03
COULTER CLONE GAM-FITC POLY ANTI (IGG & IGM) (K893419)Coulter Immunology1989-08-03
IFA SENSIBAC POLYMYXIN B (K892723)Investigacion Farmaceutica S.A. DE C.V.1989-08-03
ABUSCREEN ONTRAK POS.REF.CONTROL FOR PHENCYCLIDINE (K893860)Roche Diagnostic Systems, Inc.1989-08-03
CLINIMATE-TDA BLOOD CHEMISTRY ANALYZER (K893547)Heraeus Kulzer, Inc.1989-08-03
GAMMA LOCKING NAIL (K893639)Howmedica Corp.1989-08-03
ABUSCREEN ONTRAK POS. REF. CONTROL FOR AMPHETAMINE (K893857)Roche Diagnostic Systems, Inc.1989-08-03
SERATEST ENA [SCL-70] KIT (K894411)Hemagen Diagnostics, Inc.1989-08-02
CYSTO APRONS IN VARIOUS SIZES (K893842)Bemiss Jason Corp.1989-08-02
MEDTRONIC INTRAVASCULAR BLOOD GAS MONITORING (K891013)Medtronic Vascular1989-08-02
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