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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
120697–120720 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 26, 1991
MINIVAGE(R)
K911919 · KDH
Autovage
Gastroenterology & Urology · 87d
Cleared Jul 26, 1991
BONE NAIL, KUNTSCHER
K911982 · HSD
International Hospital Supply Co.
Orthopedic · 84d
Cleared Jul 26, 1991
MULTITOME MODEL 1000, VITRECTOMY DRIVING SYSTEM
K911998 · HQE
Allergan Medical Optics
Ophthalmic · 88d
Cleared Jul 26, 1991
ROBOTIC SAMPLE PROCESSOR
K912036 · JQW
Tecan U.S., Ltd.
Chemistry · 79d
Cleared Jul 26, 1991
ABUSCREEN(R) ONLINE(TM) THC CALIBRATORS
K912048 · DLJ
Roche Diagnostic Systems, Inc.
Toxicology · 78d
Cleared Jul 26, 1991
CEDIA(R) TOBRAMYCIN ASSAY
K912143 · LFW
Microgenics Corp.
Toxicology · 72d
Cleared Jul 26, 1991
URETERAL CATHETER HOLDER
K912146 · KNY
Inman Liebelt Corp.
Gastroenterology & Urology · 72d
Cleared Jul 26, 1991
COX DIAPOSABLE POLYPECTOMY SNARE
K912254 · FDI
Cox Medical Ent., Inc.
Gastroenterology & Urology · 66d
Cleared Jul 26, 1991
ARTEMA AQUA+
K912333 · BYD
Artema Medical AB
Anesthesiology · 63d
Cleared Jul 26, 1991
ARTEMA AQUA+ T & TS
K912334 · BYD
Artema Medical AB
Anesthesiology · 63d
Cleared Jul 26, 1991
ARTEMA AQUA+ N
K912335 · BYD
Artema Medical AB
Anesthesiology · 63d
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