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
85585–85608 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 29, 1999
PVC (POLYVINYL CHLORIDE) SYNTHETIC EXAMINATION GLOVES, POWDERED
K992100 · LYZ
Shanghai Palomar Mountain Industries,...
General Hospital · 38d
Cleared Jul 29, 1999
NITRILE EXAMINATION GLOVES- PRE-POWDERED, SMALL, MEDIUM, AND LARGE
K992177 · LZA
Pt. Berlian Glovindo
General Hospital · 31d
Cleared Jul 29, 1999
GORE-TEX DUALMESH BIOMATERIAL
K992189 · FTL
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 30d
Cleared Jul 29, 1999
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K992206 · LYZ
Shanghai China Star Corp
General Hospital · 29d
Cleared Jul 29, 1999
QUICK-SERTER, MODEL 395
K992300 · KZH
Medtronic Minimed
General Hospital · 21d
Cleared Jul 28, 1999
VOYAGER QUAD CANNULA
K983270 · DWF
Cardiothoracic Systems, Inc.
Cardiovascular · 314d
Cleared Jul 28, 1999
AUTOMATED CELLULAR IMAGING SYSTEM (ACIS)
K984188 · JOY
Chroma Vision Medical Systems, Inc.
Hematology · 247d
Cleared Jul 28, 1999
DADE BEHRING BFTII
K984501 · JPA
Dade Behring, Inc.
Hematology · 222d
Cleared Jul 28, 1999
CRYOCHECK LA SURE, MODEL SUR25-10
K990580 · GIR
Precision Biologic
Hematology · 155d
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