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
82921–82944 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 22, 2000
MARSPO2, MODEL 2001
K993979 · DQA
Novametrix Medical Systems, Inc.
Anesthesiology · 90d
Cleared Feb 22, 2000
LEIBINGER QUIK DISK TITANIUM CLAMP SYSTEM
K993990 · GXN
Stryker Instruments
Neurology · 90d
Cleared Feb 22, 2000
CONTACLAIR MULTI-PURPOSE CONTACT LENS SOLUTION
K994021 · LYL
Strieter Clinical Research...
Ophthalmic · 88d
Cleared Feb 22, 2000
REMOTEIMAGE SYSTEM
K994228 · LLZ
Etrauma.Com Corp.
Radiology · 69d
Cleared Feb 22, 2000
SIMS PORTEX ANESTHESIA CATHETER
K994275 · FRN
Sims Portex, Inc.
General Hospital · 64d
Cleared Feb 18, 2000
CREATININE-S ASSAY, MODEL 221-30, 221-50, 221-17
K000055 · CGX
Diagnostic Chemicals , Ltd.
Chemistry · 42d
Cleared Feb 18, 2000
FLOCATH
K000070 · KOD
Rusch Intl.
Gastroenterology & Urology · 39d
Cleared Feb 18, 2000
HARDYDISK, CEFAZOLIN, 30MCG
K000128 · JTN
Hardy Diagnostics
Microbiology · 31d
Cleared Feb 18, 2000
ALLERGEN IMMUNOCAP, MODELS C74, E89, EX2, EX70, EX71, EX73, FX8, FX9, FX10,...
K000132 · DHB
Pharmacia & Upjohn Co.
Immunology · 31d
Cleared Feb 18, 2000
SMART SHIELD NON-STERILE POWDER-FREE PEPPERMINT SCENTED GREEN LATEX...
K000156 · LYY
Shield Gloves Manufacturer (M) Sdn Bhd
General Hospital · 30d
Cleared Feb 18, 2000
ACTION AF-1 WHEELCHAIR
K000174 · IOR
Invacare Corp.
Physical Medicine · 29d
Cleared Feb 18, 2000
ACCESS MYOGLOBIN ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33310, 33315,...
K000196 · DDR
Beckman Coulter, Inc.
Chemistry · 28d
Cleared Feb 18, 2000
ROYAL SHIELD NON-STERILE PURPLE (PINK/BLUE) COLORED POWDERED LATEX EXAM WITH...
K000217 · LYY
Shield Gloves Manufacturer (M) Sdn Bhd
General Hospital · 25d
Cleared Feb 18, 2000
RX G-UNIVERSAL
K000360 · EJT
Jeneric/Pentron, Inc.
Dental · 14d
Cleared Feb 18, 2000
MODIFICATION TO ZEUS SCIENTIFIC, INC., TPO IGG ELISA TEST SYSTEM
K000362 · JZO
Zeus Scientific, Inc.
Immunology · 14d
Cleared Feb 18, 2000
MODIFICATION TO ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM
K000363 · DDC
Zeus Scientific, Inc.
Immunology · 14d
Cleared Feb 18, 2000
MICROSTREP PLUS PANEL, LEVOFLOXACIN
K983943 · JWY
Dade Microscan, Inc.
Microbiology · 470d
Cleared Feb 18, 2000
ASP-100, MODEL 2100
K991345 · MQL
Vitrolife Sweden AB
Obstetrics & Gynecology · 305d
Cleared Feb 18, 2000
MRS-TITAN
K992359 · LZO
Rotec Medizintechnik GmbH
Orthopedic · 219d
Cleared Feb 18, 2000
MED-GUARD SURGEON'S GOWN
K992445 · FYA
Kappler USA
General Hospital · 211d
Cleared Feb 18, 2000
PERCUGUARD
K992539 · LZB
Digit-Pro
General Hospital · 203d
Cleared Feb 18, 2000
IBC VRV, MODEL 1350
K992657 · DWD
International Biophysics Corp.
Cardiovascular · 193d
Cleared Feb 18, 2000
SPOT ENDOSCOPIC MARKER
K993951 · NBG
Chek-Med Systems
Gastroenterology & Urology · 88d
Cleared Feb 18, 2000
CRYO-HIT
K993965 · GEH
Galil Medical , Ltd.
General & Plastic Surgery · 87d