Atlas FDA

1991

4,235 FDA 510(k) clearances · Clearance year

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RecordFirmDate
VS1G (K912297)Metalor Dental USA Corp.1991-06-26
PHONAK PHONICA MODEL 312-SC ITE HEARING INSTRUMENT (K912571)Phonak, Inc.1991-06-26
STANDARD S33 (K912309)Metalor Dental USA Corp.1991-06-26
DELFIA(R) 17 -OH-PROGESTERON KIT (K912026)Pharmacia Diagnostics, Inc.1991-06-25
MAINSTER HIGH MAGNIFICATION LASER LENS (K912366)Ocular Instruments, Inc.1991-06-25
GEMINI OPHTHALMIC SURGERY SYSTEM (K911808)Alcon Laboratories1991-06-25
PRESSURE LIMITING ELBOW WITH MANOMETER PORT (K911298)Intertech Resources, Inc.1991-06-25
KEELER PULSAIR NON CONTACT TONOMETER, MODIFICATION (K911721)Keeler Instruments, Inc.1991-06-25
CATHSCANNER(R) VISIONS(TM) 3.5F 54700/5.0F 54600 (K911384)Endosonics Corp.1991-06-25
.010 HI-TORQUE GUIDE WIRES WITH PRESHAPED TIP (K911460)Advanced Cardiovascular Systems, Inc.1991-06-25
SLIMCATH (TM) (K903001)Gynopharma, Inc.1991-06-25
TURBO SUPPORT CATHETER (K910116)Datascope Corp.1991-06-25
MEHIGAN-PILLING ANGIOSCOPIC VASCULAR INSTRUM. LINE (K911099)Pilling Co.1991-06-25
NEUROMUSCULAR TRANSMISSION MONITOR (K905092)Utah Medical Products, Inc.1991-06-25
SURGITEK(R) ERCP CONTRAST MEDIA SYSTEM (K910769)Surgitek Medical Engineering Corp.1991-06-25
MOSS- ANCHOR SET (K910910)Moss Medical Products1991-06-24
LATERALASE TM (K903418)Trimedyne, Inc.1991-06-24
MTS KNEE SYSTEM (K905613)T & R Mfg., Inc.1991-06-24
SX90 (TM),MODEL 4800S (K912348)Medical Devices, Inc.1991-06-24
CROATEST (R) RHEUMATOID DIAGNOSTIC (K904416)Biotrax, Inc.1991-06-24
CATHETER MOUNTS (K911421)Intersurgical, Inc.1991-06-24
ACCESSORIES & CONNECTORS, 22MM-15MM-8.5MM (K911425)Intersurgical, Inc.1991-06-24
INFANT NASAL CANNULAE ASSEMBLY, MODIFIED (K911780)Ackrad Laboratories1991-06-24
INTERVASCULAR ADMINSTRATION SET (K911753)Mcgaw, Inc.1991-06-24
MICROZYME(TM) FREE T4 ENZYME IMMUNOASSAY TEST (K911634)Immunotech Corp.1991-06-24
FLO-GARD 6300 DUAL CHANNEL VOLUMETRIC INFUSION PUM (K910934)Baxter Healthcare Corp1991-06-24
EMC MODEL NO. STATOME 900 (K911353)Emc Industries1991-06-24
IRRIGATION/ASPIRATION TUBING SET (K911324)Biomedical Dynamics, Inc.1991-06-24
OBA(TM) SERUM HCG ASSAY (K911047)Adeza Biomedical1991-06-24
COLOR VUE TM- MYCOPLASMA PNEUMONIAE (K910833)Seradyn, Inc.1991-06-24
TMP MANDIBULAR COMPRESSION SYSTEM (K905024)Techmedica, Inc.1991-06-24
BIOVISION EMERALD LASER PHOTOCOAGULATOR (K895363)F.I.T. of France1991-06-24
HGM ARGON ION & SOLID LIGHT LASER FOR DENTISTRY (K910602)Hgm Medical Laser Systems, Inc.1991-06-24
FASTTECH SYSTEM 1 (K911496)3M Diagnostic Systems, Inc.1991-06-24
MODEL 2100 PORTABLE FIELD UNIT (K911506)Dntl Corp.1991-06-24
MODEL 700 LAPAROSCOPIC ELECTRONIC INSUFFLATOR (K912044)Multigon Industries, Inc.1991-06-24
HARMONIC SCALPEL ENDOSCOPIC BLADE COUPLER EXTENSIO (K911341)Ultracision, Inc.1991-06-24
HARDCOATED PLASTIC FILLING INSTRUMENT (K912149)Premier Dental Products Co.1991-06-24
INTERLINK(TM) BLUNT CANNULA, MODIFICATION (K911868)Baxter Healthcare Corp1991-06-24
(CP) TITANIUM AND TI6AI-4V ALLOY FOR FIXED PROSTHE (K901552)Nobelpharma USA, Inc.1991-06-24
SEAL-RITE SILICONE EAR PLUG (K910177)Flents Products Co., Inc.1991-06-24
L582 TRANSDUCER (K904600)Acuson Corp.1991-06-24
OBA(TM) READER (K911045)Adeza Biomedical1991-06-24
BIPOLAR FORCEPS (K912544)Everest Medical Corp.1991-06-24
VITAL-PORT VASCULAR ACCESS SYSTEM (K911449)Med Institute, Inc.1991-06-24
CATHLAB SILICONE OCCLUSION BALLOON CATHETER (K910916)Cathlab Corp.1991-06-24
VISUWELL SYPHILIS ANTIGEN (K910487)Adi Diagnostics, Inc.1991-06-24
MODEL 404-SP AND 504-SP INFUSION PUMPS MODIFIED (K912458)Medtronic Minimed1991-06-24
VITEK GRAM NEGATIVE IDENTIFICATION CARD, MODIFIED (K911429)Vitek Systems, Inc.1991-06-24
BARD ALFENTANIL INFUSER (K904890)C.R. Bard, Inc.1991-06-24
POCKET DOP 3 (K910462)Imex Medical Systems, Inc.1991-06-24
SONO-VU US(TM) (K904583)E-Z-Em, Inc.1991-06-24
MONARCH STERILIZATION CONTAINER SYST, MODIFICATION (K911760)Monarch Products, Inc.1991-06-24
4.5F IMAGECATH ANGIOSCOPE (K905083)Baxter Healthcare Corp1991-06-21
MICRODELTA, TC-99M-MAG3 RENAL PROCESSING PROGRAM (K905074)Siemens Gammasonics, Inc.1991-06-21
MEHIGAN-PILLING PHLEBETOME TM (K911100)Pilling Co.1991-06-21
AGARRELIEF 10 TRANSCUTANEOUS ELEC NERVE STIMULATOR (K905526)Agar Ginosar Electronics1991-06-21
SYRINGE TIP CAP (K911638)Concord/Portex1991-06-21
RIGID ENDOSCOPE (K911348)Bruel & Kjaer1991-06-21
PCA MTK II TOTAL KNEE SYSTEM (K910235)Howmedica Corp.1991-06-21
EURO-DIAGNOSTIC BLOOD PRESSURE MONITOR (K904298)Medi-Swiss Corp.1991-06-21
BERLEX BOLUS/INFUSION(TM) INTRAVENOUS ADMIN SET (K905518)Venusa , Ltd.1991-06-21
ISOLA(TM) SPINE SYSTEM--EYE ROD (K911394)Acromed Corp.1991-06-21
AGFA DIAGNOSTIC CENTER (ADC) (K904519)Enhanced Imaging Technologies, Inc.1991-06-21
LYME IGM ELISA TEST (K903013)Gull Laboratories, Inc.1991-06-21
MAGNETIC RESONANCE DEVICE ACCESSORY (MRT-50A) (K911495)Toshiba America Mri, Inc.1991-06-21
ECG FEMALE-TO-PIN SNAP ELECTRODE W/LEADS AND EXT. (K911990)Somnitec, Inc.1991-06-21
FIXATION DEVICES AND BONE PLATE (K910175)Micro Surgical Instruments Corp.1991-06-21
BIOCLONE'S ELEGANCE IGE ELISA KIT (K910419)Bioclone Australia Pty , Ltd.1991-06-21
ABUSCREEN FP FOR CANNABINOIDS (15-50) (K910592)Roche Diagnostic Systems, Inc.1991-06-21
SOFT HYDROXYLAPATITE OSSICULAR MALLEABLE PROSTHES (K904239)Microbio-Medics, Inc.1991-06-21
NDI MODEL IRS-TD (K904676)National Diagnostic Imaging, Inc.1991-06-21
RX-5000 MRI SYSTEM (K911892)Resonex, Inc.1991-06-20
MEDISYSTEMS HEMODIALYSIS FISTULA SET (K910734)Medisystems Corp.1991-06-20
FLEXIBLE CHOLEDOCHOSCOPE (K911480)United States Endoscopy Group, Inc.1991-06-20
MEGA LUMBAR PUNCTURE KIT (K910089)Megadyne Medical Products, Inc.1991-06-20
DISPOSABLE SPECIMEN BAG W/CANNULA AND INTRODUCER (K911262)ETHICON, Inc.1991-06-20
OBTRASOUND STETHOSCOPE FETAL CALC (K911453)Medasonics, Inc.1991-06-20
MEADOX(R) SURGIMED(R) BIOPSY GUN II (K911635)Meadox Surgimed, Inc.1991-06-20
STRATUS(R) HTSH FLUORMETRIC ENZYME IMMUNOASSAY (K912241)Baxter Healthcare Corp1991-06-20
MICROSTIM 100 MODEL 2C (K910580)Microstim, Inc.1991-06-20
BIPROBE(TM) (K912601)C.R. Bard, Inc.1991-06-20
NEONATAL TSH (125I) IMMUNORADIOMETRIC ASSAY (K912324)Bd Becton Dickinson Vacutainer Systems Preanalytic1991-06-20
THOROCENTESIS KIT (K910963)Megadyne Medical Products, Inc.1991-06-20
UNIPOLAR COAGULATOR PROBE SYSTEM (K911274)American Surgical Instruments Corp.1991-06-20
TELEX MODEL TLP, IN-THE-EAR (K912204)Telex Communications, Inc.1991-06-20
MODIFIED MODELS 2000W AND 2000W OPTION H APNEA MON (K905575)Edentec Corp.1991-06-20
IMMULITE(TM) HCG (K911796)Cirrus Diagnostics, Inc.1991-06-20
ZODIAC 901 MIDDLE-EAR ANALYZER (K910247)Madsen Electronics (Canada) , Ltd.1991-06-19
PORTABLE AUTO TRANSFUSION SYSTEM 500 (K910238)Electromedics, Inc.1991-06-19
KONTRON INTRA-AORTIC BALLOON PUMP, MODEL KAAT II (K905313)Kontron Instruments, Inc.1991-06-19
GASTROSCAN (K905154)Medics Instrument Corp.1991-06-19
OSTEONICS 7000 SERIES TOTAL KNEE TIBIAL COMPONENTS (K910990)Osteonics Corp.1991-06-19
CHOLANGIOCATH AND ATRAUMATIC BOWEL CLAMP (K911243)Northgate Technologies, Inc.1991-06-19
VARIOUS X-RAY TUBES (K911695)Comet Ltd. C/O Radiology Resources, Inc.1991-06-19
BIVONA WIRE REINFORCED PEDIATRIC TRACHEOSTOMY TUBE (K912469)Bivona Medical Technologies1991-06-19
INTRAN PLUS (K905563)Utah Medical Products, Inc.1991-06-19
MGA-IR SIDESTREAM PCO2 MODULE (K904863)Marquette Gas Analysis Corp.1991-06-19
EXTERNAL PACEMAKER ANALYZER MODEL PMA-1 (K903966)Bio-Tek Instruments, Inc.1991-06-19
XEMEX ENTERAL NUTRITION CATHETER NASOGAS. TYPE A (K905573)Zeon Medical Corp.1991-06-19
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Every clearance here is in the API, with alerts when new ones post.