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
118849–118872 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 05, 1991
SCLEROTHERAPY NEEDLE
K914496 · FBK
Surgitek Medical Engineering Corp.
Gastroenterology & Urology · 58d
Cleared Dec 05, 1991
GRASPING FORCEPS
K914503 · OCZ
Surgitek Medical Engineering Corp.
Gastroenterology & Urology · 57d
Cleared Dec 05, 1991
MICRO MED INC. QRS-CARD(TM) OFFICE ECG MONITOR
K914762 · DPS
Micromed
Cardiovascular · 44d
Cleared Dec 05, 1991
PHILIPS P74P BEHIND-THE-EAR HEARING AID
K915252 · ESD
Philips Hearing Instruments Co.
Ear, Nose, Throat · 17d
Cleared Dec 04, 1991
TYPE 9210 S/ECG
K903940 · DSI
S & W Medico Teknik
Cardiovascular · 464d
Cleared Dec 04, 1991
WEHRS INCUS AND INCUS-STAPES PROSTHESES
K910685 · ETB
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 288d
Cleared Dec 04, 1991
CAVOMAT
K911388 · IKN
Wiest USA, Inc.
Gastroenterology & Urology · 250d
Cleared Dec 04, 1991
SAFE II
K912082 · DTZ
Polystan A/S
Cardiovascular · 208d
Cleared Dec 04, 1991
DINAMAP PLUS PHYSIOLOGICAL MONITOR MODEL 8700
K912188 · MHX
Critikon Company, LLC
Cardiovascular · 201d
Cleared Dec 04, 1991
CMV-EA MAB TEST
K912592 · LIN
Gull Laboratories, Inc.
Microbiology · 177d
Cleared Dec 04, 1991
OPOMAT MANUAL RESUSCITATOR VENTILATOR
K912620 · BTM
Euro-Am Pharma, Inc.
Anesthesiology · 174d
Cleared Dec 04, 1991
SECURODRIP
K912660 · KMK
Op-Co Medical Products , Ltd.
General Hospital · 170d
Cleared Dec 04, 1991
WOMEN AND INFANT'S DELIVERY PACK
K912869 · HFW
Welcon, Inc.
Obstetrics & Gynecology · 159d
Cleared Dec 04, 1991
STERILE STAINLESS STEEL MONOFIL NONABSORB SURG SUT
K913185 · GAQ
Internacional Farmaceutica, S.A. DE C.V.
General & Plastic Surgery · 139d
Cleared Dec 04, 1991
ACS ULTRA-1 THROMBOPLASTIN
K913249 · GJS
Analytical Control Systems, Inc.
Hematology · 135d
Cleared Dec 04, 1991
DROLITE(TM) LIGHT SOURCE
K913273 · HJM
Vision Medical, Inc.
Ophthalmic · 134d
Cleared Dec 04, 1991
EVACU SLED
K913520 · FPP
Nexus Health Care Products , Ltd.
General Hospital · 119d
Cleared Dec 04, 1991
BANDAGE ROLL, GAUZE
K913779 · NAB
Keilei Intl., Inc.
General & Plastic Surgery · 112d
Cleared Dec 04, 1991
OPHTHALMIC STAND
K913961 · HMF
Luneau Ophtalmologie SA
Ophthalmic · 90d
Cleared Dec 04, 1991
ESPE(R) -SIL
K913965 · KLE
Espe GmbH (Us)
Dental · 90d
Cleared Dec 04, 1991
GLOBAL(TM) TOTAL SHOULDER W/DUPONT ENHANCED UHMWPE
K914000 · KWT
Depuy, Inc.
Orthopedic · 89d
Cleared Dec 04, 1991
FACSTRAK FLOW CYTOMETER
K914014 · GKZ
Bd Becton Dickinson Vacutainer...
Hematology · 86d
Cleared Dec 04, 1991
VIADERM
K914024 · KGN
Abs Life Sciences
General & Plastic Surgery · 85d
Cleared Dec 04, 1991
MULTIPLE BURN DRESSING
K914071 · NAB
Kerma Medical Products, Inc.
General & Plastic Surgery · 84d