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
84601–84624 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 09, 1999
COBE BRAT 2 AUTOLOGOUS BLOOD SALVAGE SYSTEM WITH THE CRIT-LINE HEMATOCRIT...
K991986 · CAC
Cobe Cardiovascular, Inc.
Hematology · 87d
Cleared Sep 09, 1999
KONINCKX UTERINE MANIPULATOR, KECKSTEIN-SCHIFF UTERINE MANIPULATOR, CLERMONT...
K992027 · HIH
Karl Storz Endoscopy
Obstetrics & Gynecology · 85d
Cleared Sep 09, 1999
POCKETSPACER
K992038 · CAF
Ferraris Medical, Inc.
Anesthesiology · 85d
Cleared Sep 09, 1999
AX WORKSTATION
K992073 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 83d
Cleared Sep 09, 1999
PUNCTUR-GUARD REVOLUTION HOLDER, MODEL 4750
K992091 · FMI
Bio-Plexus, Inc.
General Hospital · 80d
Cleared Sep 09, 1999
SAMSUNG RAYPAX FILM DIGITIZER
K992112 · LLZ
Samsung Sds Co., Ltd.
Radiology · 79d
Cleared Sep 09, 1999
MEDTRONIC GT2 FUSION GUIDE WIRES
K992237 · DQX
Medtronic Vascular
Cardiovascular · 69d
Cleared Sep 09, 1999
TERUMO U-100 INSULIN SYRINGE
K992802 · FMF
Terumo Medical Corp.
General Hospital · 21d
Cleared Sep 09, 1999
RENDER-PLAN 3-D
K992864 · MUJ
Precision Therapy Intl., Inc.
Radiology · 15d
Cleared Sep 08, 1999
PTFE RINGED GORE-TEX VASCULAR GRAFT
K991683 · DYF
W.L. Gore & Associates, Inc.
Cardiovascular · 114d
Cleared Sep 08, 1999
GO GLUCOSE MONITORING SYSTEM
K991754 · CGA
Lxn Corp.
Chemistry · 107d
Cleared Sep 08, 1999
IMPACT-PLUS, IMPACT-20, DP97, DP97-20, DP-POUR AND DP-REPAIR
K991996 · EBI
Denplus, Inc.
Dental · 86d
Cleared Sep 08, 1999
DEL2940 DENTAL ERBIUM LASER, DELITE DENTAL ERBIUM LASER
K992013 · GEX
Continuum Biomedical, Inc.
General & Plastic Surgery · 85d
Cleared Sep 08, 1999
INFUSION DYNAMICS POWER INFUSER MODEL M100B
K992044 · FRN
Infusion Dynamics, Inc.
General Hospital · 83d
Cleared Sep 08, 1999
MILLENNIUM GOLD
K992090 · FSY
Skytron, Div. the Kmw Group, Inc.
General & Plastic Surgery · 79d
Cleared Sep 08, 1999
SIGNA PROFILE/I MAGNETIC RESONANCE SYSTEM
K992135 · LNH
Ge Medical Systems, Inc.
Radiology · 76d
Cleared Sep 08, 1999
ECHOCARDIOGRAPHY SYSTEM SERIES 95000
K992259 · LLZ
Camtronics, Ltd.
Radiology · 64d
Cleared Sep 08, 1999
MEDI-STIM BUTTERFLY FLOWMETER, MODEL BF1000-BF2004
K992305 · ITX
Medi-Stim A/S
Radiology · 62d
Cleared Sep 08, 1999
RADIONICS XDC EXTERNAL VENTRICULAR CATHETER
K992379 · JXG
Radionics, Inc.
Neurology · 54d
Cleared Sep 08, 1999
SUREGUIDE CO2 LASER BEAM DELIVERY SYSTEM
K992472 · GEX
Clinicon Corp.
General & Plastic Surgery · 44d
Cleared Sep 08, 1999
SLIMLINE SURGICAL CLAMP
K992640 · DXC
Minumys Surgical, Inc.
Cardiovascular · 33d
Cleared Sep 08, 1999
CYNOSURE DIODERM
K992765 · GEX
Cynosure, Inc.
General & Plastic Surgery · 22d
Cleared Sep 08, 1999
DENTAPURE DP 90 CARTRIDGE, DENTAPURE DP 365 CARTRIDGE
K992893 · EIA
Mrlb Intl., Inc.
Dental · 12d
Cleared Sep 08, 1999
IMPREGUM F
K992895 · ELW
Espe Dental AG
Dental · 12d