FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
96409–96432 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 12, 1996
BASIS BABY-TEMP PACIFIER DIGITAL THEROMETER
K962991 · FLL
Polymedica Industries, Inc.
General Hospital · 42d
Cleared Sep 11, 1996
PHOTODERM PL.
K960772 · GEX
Esc Medical Systems , Ltd.
General & Plastic Surgery · 198d
Cleared Sep 11, 1996
MEDLITE/755 ALEXANDRITE LASER SYSTEM
K961006 · GEX
Continuum Biomedical, Inc.
General & Plastic Surgery · 183d
Cleared Sep 11, 1996
THYROID STIUMLATING HORMONE (TSH-BEADS ASSAY) TEST
K961629 · JLW
Teco Diagnostics
Chemistry · 138d
Cleared Sep 11, 1996
HEAD MOUNTED DISPLAY
K961800 · GCJ
Vista Medical Technologies, Inc.
General & Plastic Surgery · 125d
Cleared Sep 11, 1996
AIRLIFT BALLOON RETRACTON SYSTEM
K962104 · GCJ
Origin Medsystems, Inc.
General & Plastic Surgery · 104d
Cleared Sep 11, 1996
CLARUS MURPHYPEN ENDOSCOPE(2127-XXX)
K962255 · EOB
Clarus Medical Systems, Inc.
Ear, Nose, Throat · 91d
Cleared Sep 11, 1996
ENDOPATH ENDOSCOPIC ARTICULATING STAPLER WITH SWEIVELING CARTRIDGE TIP
K962258 · GAG
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 91d
Cleared Sep 11, 1996
MODIFIED LEVEEN NEEDLE ELECTRODE
K962313 · JOS
Radiotherapeutics Corp.
General & Plastic Surgery · 86d
Cleared Sep 11, 1996
AMO ARTHOSCOPES
K962330 · HRX
American Microptiks, Inc.
Orthopedic · 86d
Cleared Sep 11, 1996
DIOMED 15, 30, 60 SURGICAL DIODE LASER
K962354 · GEX
Lifestream Int'L, Inc.
General & Plastic Surgery · 85d
Cleared Sep 11, 1996
BONOPTY COAXIAL BONE BIOPSY SYSTEM WITH ECCENTRIC DRILL(10-1072,3,4)
K962425 · GAA
Radi Medical Systems AB
General & Plastic Surgery · 79d
Cleared Sep 11, 1996
PERTAC II/PERTAC II APLITIP
K962440 · EBF
Espe GmbH & Co. Kg.
Dental · 79d
Cleared Sep 11, 1996
HYTAC APLITIP/HYTAC OSB
K962442 · EBF
Espe GmbH & Co. Kg.
Dental · 79d
Cleared Sep 11, 1996
ENDOSCOPIC CLIP APPLIER
K962493 · OCW
Aesculap, Inc.
Gastroenterology & Urology · 77d
Cleared Sep 11, 1996
HEARTPORT ENDOAORTIC CLAMP
K962510 · DXC
Heartport, Inc.
Cardiovascular · 76d
Cleared Sep 11, 1996
ALPHA AIR HANDPIECE, ULTRA-PUSH, AL-SU, AL-MU, AL-TU
K962543 · EFB
Nsk Nakanishi, Inc.
Dental · 75d
Cleared Sep 11, 1996
STRYKER UNIVERSAL DRILL ATTACHMENTS & ACCESSORIES
K962800 · HWE
Stryker Instruments
Orthopedic · 55d
Cleared Sep 11, 1996
JAMIESON MODEL 2100 CINE FILM PROCESSOR AND KODAK CINEFLURE PROCESSOR MODEL 2100
K963334 · IXX
Jamieson Film Co.
Radiology · 16d
Cleared Sep 10, 1996
VENTANA ANTI-CD5 PRIMARY ANTIBODY
K941782 · DEH
Ventana Medical Systems, Inc.
Immunology · 883d
Cleared Sep 10, 1996
CARD GUARD MODEL CG-6500
K954350 · DXH
Card Guard Scientific Survival , Ltd.
Cardiovascular · 358d
Cleared Sep 10, 1996
FORE RUNNER EXTERNAL DEFIBRILLATOR/DEFIBRILLATOR PADS
K955628 · MKJ
Heartstream, Inc.
Cardiovascular · 274d
Cleared Sep 10, 1996
KC 40 MICRO COAGULATION ANALYZER SYSTEM (K3632)
K960875 · JPA
Sigma Diagnostics, Inc.
Hematology · 190d
Cleared Sep 10, 1996
DUAL LUMEN OXYGEN DELIVERY GAS SAMPLING CANNULA
K961150 · CCK
Hudson Respiratory Care, Inc.
Anesthesiology · 172d