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
95329–95352 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 09, 1996
PORTABLE LIQUID OXYGEN UNIT AND STATIONARY LIQUID OXYGEN UNIT
K963956 · BYJ
Southern Research, Inc.
Anesthesiology · 68d
Cleared Dec 09, 1996
EXPANDACELL ANTI-FOG INSTRUMENT WIPE (WITH ALCOHOL)/(WITHOUT)
K964334 · GCJ
Shippert Medical Technologies Corp.
General & Plastic Surgery · 39d
Cleared Dec 09, 1996
ELLIS EXTERNAL MINI-FIXATOR SYSTEM
K964458 · KTT
Link America, Inc.
Orthopedic · 32d
Cleared Dec 09, 1996
ACUMED TENSION BAND PIN
K964500 · HTY
Acu Med, Inc.
Orthopedic · 31d
Cleared Dec 09, 1996
DMS-1000C DERMOABRADER
K965256 · GFD
Mattioli Engineering, Srl
General & Plastic Surgery · 115d
Cleared Dec 06, 1996
COUPLING DEVICE FOR DENTAL PROSTHESIS
K950259 · EGG
Dr. Joseph E. Grasso, D.D.S.
Dental · 683d
Cleared Dec 06, 1996
KSEA THERMOFLATOR (MODEL 26 4320 20)
K955073 · HIF
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 396d
Cleared Dec 06, 1996
VIRAPUMP II (MODELS AND MODEL M)
K961607 · FEB
Viatro, Corp.
General Hospital · 225d
Cleared Dec 06, 1996
GALILEO HYSTEROSCOPES AND LAPAROSCOPES
K962256 · HIH
Galileo Electro-Optics Corp.
Obstetrics & Gynecology · 177d
Cleared Dec 06, 1996
MEDICAL DEVICE TECHNOLOGIES, INC.ULTRA
K962969 · KNW
Medical Device Technologies, Inc.
Gastroenterology & Urology · 128d
Cleared Dec 06, 1996
THE SAFETY 1ST DIGITAL PACIFIER
K963276 · FLL
Safety 1st, Inc.
General Hospital · 108d
Cleared Dec 06, 1996
PHILIPS SLI SERIES LINEAR ACCELERATOR
K963624 · IYE
Philips Medical Systems, Inc.
Radiology · 86d
Cleared Dec 06, 1996
MANAN PROSTATE UNI-LOCK
K963743 · IWJ
Manan Medical Products, Inc.
Radiology · 80d
Cleared Dec 06, 1996
AHS OMEGA CONCEPT
K963877 · ESD
Authorized Hearing Systems, Inc.
Ear, Nose, Throat · 71d
Cleared Dec 06, 1996
AHS OMEGA HF
K963878 · ESD
Authorized Hearing Systems, Inc.
Ear, Nose, Throat · 71d
Cleared Dec 06, 1996
ALPHA-DENT ROOT CANAL SEALER & FILLER
K963922 · KIF
Wallace A. Erickson & Co.
Dental · 67d
Cleared Dec 06, 1996
TRUBYTE SOFT RELINE SYSTEM
K964040 · EBI
Dentsply Intl.
Dental · 59d
Cleared Dec 06, 1996
STARKEY TM-3, TM-5 HIGH FREQUENCY TINNITUS MASKER
K964216 · KLW
Starkey Laboratories, Inc.
Ear, Nose, Throat · 45d
Cleared Dec 06, 1996
REMEL MEROPENEM 10UG SUSCEPTIBILITY DISK
K964421 · JTN
Remel, L.P.
Microbiology · 66d
Cleared Dec 06, 1996
CLINICAL BLOOD GAS MIXTURES
K964475 · JIS
Oxarc, Inc.
Chemistry · 29d
Cleared Dec 06, 1996
OZARK 20
K964566 · EJT
Gateway Alloys, Inc.
Dental · 22d
Cleared Dec 06, 1996
EL DORADO 75
K964567 · EJT
Gateway Alloys, Inc.
Dental · 22d
Cleared Dec 06, 1996
OZARK 46
K964568 · EJT
Gateway Alloys, Inc.
Dental · 22d
Cleared Dec 06, 1996
EL DORADO 58
K964569 · EJT
Gateway Alloys, Inc.
Dental · 22d