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
76561–76584 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 21, 2001
WIENER LAB. CA-COLOR AA, MODEL 4 X 50 ML CAT.N 1152002
K013652 · CIC
Wiener Laboratories Saic
Chemistry · 45d
Cleared Dec 21, 2001
AST (SGOT)
K013698 · CIT
Jas Diagnostics, Inc.
Chemistry · 44d
Cleared Dec 21, 2001
INSYTE, ANGIOCATH, INSYTE AUTOGUARD, ANGIOCATH AUTOGUARD, AUTOGUARD PRO,...
K013800 · FOZ
Becton Dickinson Infusion Therapy...
General Hospital · 36d
Cleared Dec 21, 2001
GLO-SPEC
K013817 · HIB
Sol Weiss MD, Inc.
Obstetrics & Gynecology · 35d
Cleared Dec 21, 2001
STANDARD A, STANDARD B, STANDARD C, CAL, SLOPE
K013850 · JIT
Diamond Diagnostics, Inc.
Chemistry · 31d
Cleared Dec 21, 2001
VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12 RANGE VERIFIERS
K013900 · JJX
Ortho-Clinical Diagnostics
Toxicology · 28d
Cleared Dec 21, 2001
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPTIBILITY PLATES
K013925 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 37d
Cleared Dec 21, 2001
MODIFICATION TO MAS CARDIOLMMUNE TL
K013995 · JJY
Medical Analysis Systems, Inc.
Chemistry · 17d
Cleared Dec 21, 2001
ENTEGRA PE PERSONAL DIGITAL ASSISTANT
K014058 · LLZ
General Electric Medical Systems
Radiology · 11d
Cleared Dec 21, 2001
BIOSCANNER PLUS
K014099 · NBW
Polymer Technology Systems, Inc.
Chemistry · 8d
Cleared Dec 20, 2001
SAUFLON MULTI LENS CARE SYSTEM
K010559 · LPN
Sauflon Pharmaceuticals, Ltd.
Ophthalmic · 297d
Cleared Dec 20, 2001
OXYLOG 1000, MODEL 2M86840
K010793 · CBK
Drager Medizintechnik GmbH
Anesthesiology · 279d
Cleared Dec 20, 2001
LORENZ LACTOSORB PANELS AND FASTENERS
K011139 · HRS
Biomet, Inc.
Orthopedic · 251d
Cleared Dec 20, 2001
FILTERFLO H
K011212 · CAH
Arc Medical, Inc.
General Hospital · 244d
Cleared Dec 20, 2001
3D LINE STEROTACTIC HARDWARE ACCESSORIES
K011255 · HAW
3D Line USA, Inc.
Neurology · 240d
Cleared Dec 20, 2001
NORIAN SRS BONE VOID FILLER
K011897 · MQV
Synthes (Usa)
Orthopedic · 185d
Cleared Dec 20, 2001
GELBISH VASCULAR DILATOR
K012256 · DRE
Vascumetrix, LLC
Cardiovascular · 155d
Cleared Dec 20, 2001
BIPAP SYNCHRONY VENTILATORY SUPPORT SYSTEM
K012323 · MNS
Respironics, Inc.
Anesthesiology · 150d
Cleared Dec 20, 2001
CSIST DICOM GATEWAY/IMAGE MANAGER
K012327 · LLZ
Csist
Radiology · 150d
Cleared Dec 20, 2001
GIMMI'ALPHA' ENDOSCOPES & ACCESSORIES
K012660 · FET
Gimmi GmbH
Gastroenterology & Urology · 129d
Cleared Dec 20, 2001
SIGN IM NAIL
K013132 · HSB
Surgical Implant Generation Network...
Orthopedic · 92d
Cleared Dec 20, 2001
PORGES SILICONE PROSTATECTOMY CATHETER, STRAIGHT CYLINDRICAL TIP, DELINOTTE...
K013172 · EZL
Porges S.A.
Gastroenterology & Urology · 87d
Cleared Dec 20, 2001
FUJI SPEED SUITE, FUJI SPEED SUTE PHASE II
K013218 · MQB
Fujifilm Medical System U.S.A., Inc.
Radiology · 85d
Cleared Dec 20, 2001
EVENFLO COMFORT EASE MANUAL BREAST PUMP KIT
K013226 · HGY
Evenflo Company, Inc.
Obstetrics & Gynecology · 84d