FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
81313–81336 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 05, 2000
VACUETTE WITH PPACK
K002777 · JKA
Greiner Vacuette North America, Inc.
Chemistry · 29d
Cleared Oct 05, 2000
PARAGON CZE 2000 CAPILLARY ELECTROPHORESIS SYSTEM AND BUFFER-100
K002799 · CFF
Beckman Coulter, Inc.
Chemistry · 27d
Cleared Oct 05, 2000
RAPID EXCHANGE TAPERTOME
K002802 · KNS
Boston Scientific Corp
Gastroenterology & Urology · 27d
Cleared Oct 05, 2000
N PROTEIN STANDARD SL
K002804 · JIX
Dade Behring, Inc.
Chemistry · 27d
Cleared Oct 05, 2000
MWO-202 3D HYDRAULIC COARSE/FINE MICROMANIPULATOR
K002850 · MQJ
Narishige Co., Ltd.
Obstetrics & Gynecology · 22d
Cleared Oct 05, 2000
ELS CANNULA (KIT), MODEL M1210-88,M1510-88
K002857 · DWF
Jostra AG
Cardiovascular · 22d
Cleared Oct 05, 2000
MODIFICATION TO BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM
K002879 · JEY
Bioplate, Inc.
Dental · 20d
Cleared Oct 04, 2000
GEUDER INJECTOR FOR MORCHER CAPSULAR TENSION RING
K001125 · NCE
Geuder GmbH
Ophthalmic · 180d
Cleared Oct 04, 2000
VIDAS H. PYLORI IGG (HPY) ASSAY, MODEL 30 192
K001460 · LYR
bioMerieux, Inc.
Microbiology · 147d
Cleared Oct 04, 2000
BROOKER TIBIA NAILS
K002057 · HSB
Biomet Orthopedics, Inc.
Orthopedic · 90d
Cleared Oct 04, 2000
AB CARDIETTE DAEDALUS VIEW BASE AND AB CARDIETTTE DAEDALUS VIEW HES
K002074 · DPS
H&C Medical Devices Spa
Cardiovascular · 86d
Cleared Oct 04, 2000
INQWIRE DIAGNOSTIC GUIDE WIRE
K002289 · DQX
Merit Medical Systems, Inc.
Cardiovascular · 69d
Cleared Oct 04, 2000
EMS SWISS ORTHOCLAST CHISELS FOR NON-CEMENTED PROSTHESIS REMOVAL
K002484 · JDX
Electro Medical Systems SA
Orthopedic · 51d
Cleared Oct 04, 2000
ASCENT XXL CLOSED BOX FEMORAL COMPONENT
K002772 · JWH
Biomet, Inc.
Orthopedic · 28d
Cleared Oct 04, 2000
PRESSURE WIRE SENSOR, MODEL 12003/12303
K002962 · DQX
Radi Medical Systems AB
Cardiovascular · 12d
Cleared Oct 03, 2000
PERCLOSE VASCULAR SUTURE DELIVERY DEVICE
K001703 · GAW
Abbott Vascular, Inc.
General & Plastic Surgery · 120d
Cleared Oct 03, 2000
BULL'S-EYE DISPOSABLE NEEDLE RECAPPING AID
K002213 · FMI
Hunter Research Laboratories, Inc.
General Hospital · 74d
Cleared Oct 03, 2000
INDOMITABLE MAGNETIC RESONANCE IMAGING SCANNER
K002490 · LNH
Fonar Corp.
Radiology · 50d
Cleared Oct 03, 2000
POLYMER COAT, POWDER FREE, LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT...
K002568 · LYY
Smart Glove Corp. Sdn Bhd
General Hospital · 46d
Cleared Oct 03, 2000
MEDIA FOR GAMETE PREPARATION AND EMBRYO CULTURE
K002836 · MQL
Sage Biopharma
Obstetrics & Gynecology · 21d
Cleared Oct 02, 2000
TORNIER TOTAL ELBOW PROSTHESIS
K000003 · JDC
Tornier
Orthopedic · 273d
Cleared Oct 02, 2000
DISPOSABLE H-PE MICROKERATOME BLADES
K001464 · HNO
Oasis
Ophthalmic · 145d
Cleared Oct 02, 2000
GLUCANPRO CREAM
K002077 · MGQ
Brennen Medical, Inc.
General & Plastic Surgery · 84d
Cleared Oct 02, 2000
BETA GLUCAN GEL (MACROPRO GEL)
K002078 · MGQ
Brennen Medical, Inc.
General & Plastic Surgery · 84d