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
85081–85104 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 28, 1999
ICS MEDICAL CHARTR ENG/VNG DIAGNOSTIC SYSTEM
K991497 · GWN
Ics Medical Corp.
Neurology · 90d
Cleared Jul 28, 1999
SACRED CRANE TDP LAMP, MODELS CQ-27, CQ-12, CQ-36
K991503 · ILY
United Pacific Co., Ltd.
Physical Medicine · 90d
Cleared Jul 28, 1999
MICROTAINER BRAND CHEMISTRY TUBES WITH MICROGARD CLOSURE, MODEL 365965,...
K991702 · JKA
Becton Dickinson Vacutainer Systems
Toxicology · 70d
Cleared Jul 28, 1999
PHARMACIA CAP SYSTEM IGE FEIA, MODEL 10-9395-01
K991945 · DGC
Pharmacia & Upjohn Co.
Immunology · 49d
Cleared Jul 28, 1999
PERFORMANCE KNEE SYSTEM
K992167 · JWH
Biomet, Inc.
Orthopedic · 30d
Cleared Jul 28, 1999
MODIFICATION TO ZYMED HOLTER 2000
K992197 · MLO
Zymed Medical Instrumentation
Cardiovascular · 28d
Cleared Jul 27, 1999
AVE 4F SITESEER CARDIOVASCULAR ANGIOGRAPHIC CATHETER
K984627 · DQO
Arterial Vascular Engineering, Inc.
Cardiovascular · 209d
Cleared Jul 27, 1999
CRYO-HIT II, MODELS EP3T3, EP5T2, EP5T5, EP7T5, EP8T5
K991517 · GEH
Galil Medical , Ltd.
General & Plastic Surgery · 88d
Cleared Jul 27, 1999
SWISS LITHOCLAST MULTIPURPOSE PROBE
K992251 · FFK
Electro Medical Systems SA
Gastroenterology & Urology · 21d
Cleared Jul 26, 1999
LUER ACCESS INJECTION SITE
K984060 · FPA
Baxter Healthcare Corp
General Hospital · 255d
Cleared Jul 26, 1999
SULLIVAN AUTOSET NASAL CPAP SYSTEM
K984428 · BZD
Resmed, Ltd.
Anesthesiology · 234d
Cleared Jul 26, 1999
WALLACE TRIAL TRANSFER CATHETER, MODEL TT 1816N
K990348 · MQF
CooperSurgical, Inc.
Obstetrics & Gynecology · 171d
Cleared Jul 26, 1999
WALLACE MALLEABLE STYLET-18CM, MODEL 1816ST, WALLACE MALLEABLE STYLET-23CM,...
K990349 · MQF
CooperSurgical, Inc.
Obstetrics & Gynecology · 171d
Cleared Jul 26, 1999
WALLACE CATHETERS-18CM, MODEL 1816
K990350 · MQF
CooperSurgical, Inc.
Obstetrics & Gynecology · 171d
Cleared Jul 26, 1999
CARESIDE PT
K991065 · GJS
Careside, Inc.
Hematology · 117d
Cleared Jul 26, 1999
REDI-TEST COCAINE
K991110 · DIO
Redwood Biotech, Inc.
Toxicology · 116d
Cleared Jul 26, 1999
ENHANCE-S PLUS
K991322 · MQL
Conception Technology, Inc.
Obstetrics & Gynecology · 98d
Cleared Jul 26, 1999
VANTAGE 2.5
K991607 · KPS
Adac Laboratories
Radiology · 77d
Cleared Jul 26, 1999
FASTRAY LC
K991631 · ELW
Harry J. Bosworth Co.
Dental · 76d
Cleared Jul 26, 1999
COMPAT JEJUNOSTOMY TUBE KIT, MODEL 088OXX (XX=16,14, OR 12)
K991668 · KNT
Novartis Nutrition Corp.
Gastroenterology & Urology · 73d
Cleared Jul 26, 1999
LC PIT & FISSURE SEALANT
K991902 · EBC
Bosworth Co.
Dental · 52d
Cleared Jul 26, 1999
PENTAMIX 2
K991913 · EFD
Espe Dental AG
Dental · 49d
Cleared Jul 26, 1999
SAFESKIN SYNTHETIC BINYO POWDER-FREE POLYMER COATED EXAMINATION GLOVES...
K991951 · LYZ
Safeskin Corp.
General Hospital · 46d
Cleared Jul 26, 1999
BRIGHTWAY BRAND LATEX SURGICAL GLOVES - STERILE (POWDERED)
K992020 · KGO
Brightsway Holdings Sdn Bhd
General Hospital · 40d