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
120433–120456 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 26, 1991
ARTEMA AQUA+ FLEX
K912336 · BYD
Artema Medical AB
Anesthesiology · 63d
Cleared Jul 26, 1991
MULTICHANNEL RECORDING SYSTEM
K912427 · DSH
Bionique
Cardiovascular · 56d
Cleared Jul 26, 1991
3M WATER DISPERSIBLE ADHESIVE TAPE, 98XX
K912520 · KGX
3M Health Care, Ltd.
General & Plastic Surgery · 50d
Cleared Jul 26, 1991
MODEL 4205 PULSE GENERATOR SURGICAL EXTEN CABLE
K912545 · DXY
Pace Medical
Cardiovascular · 46d
Cleared Jul 26, 1991
THE VOSS DISPOSABLE SUCTION/IRRIGATION CANNULA
K912579 · GCJ
Voss Products
General & Plastic Surgery · 45d
Cleared Jul 26, 1991
ABUSCREEN RADIOIMMUNOASSAY FOR COCAINE METABOLITE
K912756 · KLN
Roche Diagnostic Systems, Inc.
Toxicology · 35d
Cleared Jul 26, 1991
ABUSCREEN RADIOIMMUNOASSAY FOR CANNABINIODS
K912757 · LDJ
Roche Diagnostic Systems, Inc.
Toxicology · 35d
Cleared Jul 26, 1991
ABUSCREEN ONLINE FOR AMPHETAMINES
K912758 · DKZ
Roche Diagnostic Systems, Inc.
Toxicology · 35d
Cleared Jul 26, 1991
SOMNIMIC (R)
K912817 · LEL
Somnitec, Inc.
Neurology · 66d
Cleared Jul 26, 1991
MAGNESIUM ASSAY KIT, CAT.# 100-12
K912825 · JGJ
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 30d
Cleared Jul 26, 1991
WHOLE BLOOD ALCOHOL CONTROL, LEVEL 1 & 2
K912826 · DKC
Cala Diagnostics
Chemistry · 30d
Cleared Jul 26, 1991
SHUR-GRIP
K912834 · KDC
Inman Medical Corp.
General & Plastic Surgery · 30d
Cleared Jul 26, 1991
MICROTRAK MANAGER
K912959 · JJQ
Syva Co.
Chemistry · 18d
Cleared Jul 26, 1991
MONOSCOPY BRAND 5MM LOCK TROCAR SLEEVE, MODIFIED
K912980 · GCJ
Dexide, Inc.
General & Plastic Surgery · 32d
Cleared Jul 26, 1991
ABBOTT QUICKSTART GAMMA-GLUTAMYTRANSFERASE TEST
K913024 · JQB
Em Diagnostic Systems, Inc.
Chemistry · 17d
Cleared Jul 25, 1991
GATES GLIDDEN DRILLS
K905418 · DZA
The Hygenic Corp.
Dental · 233d
Cleared Jul 25, 1991
DIMAC WIRES
K910090 · DYX
Instrumentations Unltd.
Dental · 197d
Cleared Jul 25, 1991
WYMAN SUTURE WASHER
K910186 · HTN
Acu Med, Inc.
Orthopedic · 191d
Cleared Jul 25, 1991
PRECISE BARND PI DISPOSABLE SURGICAL STAPLES
K911252 · GDW
3M Medical Products Group
General & Plastic Surgery · 126d
Cleared Jul 25, 1991
BRANEMARK SYSTEM-5.0MM FIXTURE
K911961 · DZE
Nobelpharma USA, Inc.
Dental · 84d
Cleared Jul 25, 1991
SHEPARD CRYOPRESS/CAMP MULTI-TEMP SPORT PUMPS
K912004 · IRP
Shepherd Medical Products, Inc.
Physical Medicine · 80d
Cleared Jul 25, 1991
DISPOSABLE O.R. TOWEL
K912110 · KKX
American Threshold Industries, Inc.
General Hospital · 73d
Cleared Jul 25, 1991
TBD, LENS MEASURING DEVICE
K912134 · HRJ
Alcon Laboratories
Ophthalmic · 72d
Cleared Jul 25, 1991
LANDERS THREE STRUT VITRECTOMY LENS RING
K912151 · HNH
Ocular Instruments, Inc.
Ophthalmic · 71d