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
83425–83448 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 22, 2000
SYNTHETIC (WHITE) VINAL POWDERED PATIENT EXAMINATION GLOVES
K000166 · LYZ
Shijiazhuang Great Eagle Plastic...
General Hospital · 34d
Cleared Feb 22, 2000
ENTEC CONTROLLER, ENTEC PATIENT CABLE, FOOTSWITCH, POWERCORD, PLASMA WAND
K000228 · GEI
Arthrocare Corp.
General & Plastic Surgery · 26d
Cleared Feb 22, 2000
10 CURIE IRDIUM 192, CSN00100-192
K991571 · KXK
Alpha-Omega Services, Inc.
Radiology · 293d
Cleared Feb 22, 2000
OXYCON PRO
K992214 · BZC
Erich Jaeger B.V.
Anesthesiology · 236d
Cleared Feb 22, 2000
STEALTHSTATION TREATMENT GUIDANCE PLATFORM
K992461 · HAW
Surgical Navigation Technologies, Inc.
Neurology · 214d
Cleared Feb 22, 2000
PERI-STRIPS-SLEEVE, PERI-STRIPS-STRIP AND PERI-STRIPS DRY (NON-NAOH-TREATED...
K992537 · FTM
Bio-Vascular, Inc.
General & Plastic Surgery · 208d
Cleared Feb 22, 2000
LEMAITRE BALLOON CATHETER WITH IRRIGATION
K992940 · DXE
Vascutech, Inc.
Cardiovascular · 175d
Cleared Feb 22, 2000
SIEMENS INFINITY SC 6002XL PORTABLE PATIENT MONITOR
K993974 · MHX
Siemens Medical Solutions USA, Inc.
Cardiovascular · 90d
Cleared Feb 22, 2000
PATHWAY VAGINAL EMG/STIM PERINEOMETER SENSOR, PATHWAY ANAL EMG/STIM...
K993976 · KPI
The Prometheus Group
Gastroenterology & Urology · 90d
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