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
85105–85128 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 10, 1999
COSMAN ROBERT WELLS FUNCTIONAL PROBE MICRODRIVE
K992721 · HAW
Radionics, Inc.
Neurology · 28d
Cleared Sep 09, 1999
PHILIPS EASYVISION WORKSTATION:
K990335 · LNH
Philips Medical Systems North...
Radiology · 218d
Cleared Sep 09, 1999
DOUBLE LUMEN NEEDLE
K991020 · MQE
Intl., Inc.
Obstetrics & Gynecology · 164d
Cleared Sep 09, 1999
SPERM WASHING MEDIA
K991022 · MQL
Intl., Inc.
Obstetrics & Gynecology · 164d
Cleared Sep 09, 1999
SINGLE LUMEN NEEDLE
K991262 · MQE
Intl., Inc.
Obstetrics & Gynecology · 149d
Cleared Sep 09, 1999
SINGLE LUMEN SIDEPORT NEEDLE
K991264 · MQE
Intl., Inc.
Obstetrics & Gynecology · 149d
Cleared Sep 09, 1999
EMBRYO TRANSFER CATHETER CC GLIDER
K991266 · MQF
Intl., Inc.
Obstetrics & Gynecology · 149d
Cleared Sep 09, 1999
CHOLESTECH LDX ALANINE AMINOTRANSFERASE (ALT), MODEL 11-772
K991834 · CKD
Cholestech Corp.
Chemistry · 104d
Cleared Sep 09, 1999
HEALTH-PLUS, SANITEX, RELIANCE, PRE-POWDERED LATEX EXAMINATION GLOVES WITH...
K991969 · LYY
Pamitex Industries Sdn Bhd
General Hospital · 90d
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