FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
111601–111624 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 30, 1993
ARGYLE TURKEL SAFETY PNEUMOTHORAX PROCEDURE TRAY
K934428 · LRO
Sherwood Medical Co.
General & Plastic Surgery · 111d
Cleared Dec 30, 1993
KERR OPTIBOND, MODIFICATION
K934690 · KLE
Kerr Corporation (Danbury)
Dental · 157d
Cleared Dec 29, 1993
MAXIVIEW DIAGNOSTIC WORKSTATION
K930500 · LMD
Dimensional Medicine, Inc.
Radiology · 331d
Cleared Dec 29, 1993
ABUSCREEN ONLINE LOW-CUTOFF CALIBRATORS
K932548 · DLJ
Roche Diagnostic Systems, Inc.
Toxicology · 217d
Cleared Dec 29, 1993
BRAT 2 AUTOLOGUS BLOOD SALVAGE SYSTEM
K933625 · CAC
Cobe Cardiovascular, Inc.
Anesthesiology · 163d
Cleared Dec 29, 1993
BEECH PROLOK
K933732 · FPA
Beech Medical, Inc.
General Hospital · 149d
Cleared Dec 29, 1993
BEECH VERSA LOK
K933749 · FPA
Beech Medical Products, Inc.
General Hospital · 148d
Cleared Dec 29, 1993
PRO-LOK EXTENSION SET
K933852 · FPA
Beech Medical Products, Inc.
General Hospital · 145d
Cleared Dec 29, 1993
PHX TECHNOLOGIES CORP., GRASPER-RETRACTOR DEVICE
K933895 · GCJ
Phx Technologies Corp.
General & Plastic Surgery · 141d
Cleared Dec 29, 1993
BIOTRACK VALPROIC ACID TEST CARTRIDGE
K934061 · LEG
Biotrack, Inc.
Toxicology · 132d
Cleared Dec 29, 1993
BIOTRACK THERAPEUTIC DRUG-MONITORING QUAL CONTROLS
K934062 · DIF
Biotrack, Inc.
Toxicology · 132d
Cleared Dec 29, 1993
CEDIA DIGOXIN PLUS ASSAY
K934168 · KXT
Microgenics Corp.
Toxicology · 124d
Cleared Dec 29, 1993
CLEARVIEW POSITIVE AND NEGATIVE HCG URINE CONTROL SET
K934922 · JJX
Unipath , Ltd.
Chemistry · 77d
Cleared Dec 29, 1993
CLEARVIEW POSITIVE AND NEGATIVE URINE HCG CONTOL SET
K934923 · JJX
Unipath , Ltd.
Chemistry · 77d
Cleared Dec 29, 1993
OLYMPIC AUTO-LENGTH
K934930 · FTY
Olympic Medical Corp.
General & Plastic Surgery · 76d
Cleared Dec 29, 1993
PHENCYCLIDINE EIA ASSAY
K935320 · LCM
Diagnostic Reagents, Inc.
Toxicology · 76d
Cleared Dec 29, 1993
NAMTAI
K935652 · DXN
Nam Tai Electronics (Canada) , Ltd.
Cardiovascular · 36d
Cleared Dec 27, 1993
IMMUNOCARD MONO
K930778 · KTN
Meridian Diagnostics, Inc.
Immunology · 314d
Cleared Dec 27, 1993
DUODERM IMPROVED CGF CONTROL GEL FORMULA DRESSING
K932101 · MGQ
Convatec, A Division of E.R. Squibb &...
General & Plastic Surgery · 238d
Cleared Dec 27, 1993
IDEIA(TM) ROTAVIRUS
K932384 · LIQ
Dako Diagnostics , Ltd.
Microbiology · 224d
Cleared Dec 27, 1993
3M TEGADERM HP TRANSPARENT DRESSING
K932422 · KGX
3M Health Care, Ltd.
General & Plastic Surgery · 222d
Cleared Dec 27, 1993
INNERDYNE MEDICAL LAPAROSCOPIC SPHINCTEROTOMY KIT
K932692 · GCJ
Innerdyne Medical, Inc.
General & Plastic Surgery · 207d
Cleared Dec 27, 1993
PATIENT CABLE
K932704 · DSA
Sentry Medical Products, Inc.
Cardiovascular · 207d
Cleared Dec 27, 1993
AVOXIMETER
K932954 · DQK
A-Vox Systems, Inc.
Cardiovascular · 193d