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
134449–134472 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 04, 1988
ELECTRONIC DIGITAL THERMOMETER
K883005 · FLL
Hanson Scale Co.
General Hospital · 17d
Cleared Aug 04, 1988
ATS SCHAUDINN'S FIXATIVE W/ACETIC ACID
K883062 · LDW
Alpha-Tec Systems, Inc.
Pathology · 16d
Cleared Aug 03, 1988
TASH PILOT SYSTEM
K874417 · ITI
Everest & Jennings, Inc.
Physical Medicine · 280d
Cleared Aug 03, 1988
WELLCOZYME HSV WZO2
K875311 · GQN
Wellcome Diagnostics
Microbiology · 218d
Cleared Aug 03, 1988
MILLER/GALANTE PRECOAT UNICOMPARTMENTAL KNEE
K880155 · HSX
Zimmer, Inc.
Orthopedic · 203d
Cleared Aug 03, 1988
VISION(R) TOTAL BILIRUBIN WITH A NEONATAL CLAIM
K880437 · CIG
Abbott Laboratories
Chemistry · 183d
Cleared Aug 03, 1988
COLORGENE HSV DNA HYBRIDIZATION TEST
K880604 · GQN
Enzo Biochem, Inc.
Microbiology · 173d
Cleared Aug 03, 1988
ACS HI-TORQUE FLOPPY/FLOPPY II/INTER./STANDARD GW
K881897 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 89d
Cleared Aug 03, 1988
FIAX TEST KIT FOR EB-VCA-G ANTIBODY
K882023 · LSE
Whittaker Bioproducts, Inc.
Microbiology · 78d
Cleared Aug 03, 1988
FITC MURINE MONOCLONAL ANTI-CMV IGG
K882024 · GQH
Whittaker Bioproducts, Inc.
Microbiology · 78d
Cleared Aug 03, 1988
MEDIBLEND (TM) MEDICAL LASER GAS MIXTURES
K882208 · GEX
Linde Div. Union Carbide Corp.
General & Plastic Surgery · 69d
Cleared Aug 03, 1988
STERILE DISPOSABLE SURGICAL GOWNS
K882470 · FYA
Bolden Products, Div. of the...
General Hospital · 49d
Cleared Aug 03, 1988
THREE-COMPONENT MEDICAL LASER GAS MIXTURES
K882516 · GEX
Matheson Gas Products, Inc.
General & Plastic Surgery · 44d
Cleared Aug 03, 1988
REPAK SURGICAL PACKS - GOWN/TOWEL/MAJOR/DRAPE/BAS.
K882684 · LRO
Standard Textile Co., Inc.
General & Plastic Surgery · 34d
Cleared Aug 03, 1988
GAUZE PACKING, X-RAY DETECTABLE
K882707 · GDY
Bioseal
General & Plastic Surgery · 37d
Cleared Aug 03, 1988
GAUZE SPONGE, X-RAY DETECTABLE
K882708 · GDY
Bioseal
General & Plastic Surgery · 37d
Cleared Aug 03, 1988
TONSIL SPONGE, X-RAY DETECTABLE, W/STRING
K882709 · GDY
Bioseal
General & Plastic Surgery · 37d
Cleared Aug 03, 1988
INTESTINAL SPONGES
K882710 · EFQ
Bioseal
General & Plastic Surgery · 37d
Cleared Aug 03, 1988
GAUZE SPONGE 12PLY
K882711 · EFQ
Bioseal
General & Plastic Surgery · 37d
Cleared Aug 03, 1988
STICK SPONGE
K882712 · EFQ
Bioseal
General & Plastic Surgery · 37d
Cleared Aug 03, 1988
MICROTEK PROBE DRAPE
K882724 · KKX
Microbio-Medics, Inc.
General Hospital · 33d
Cleared Aug 03, 1988
VITAL-VUE ILLUMINATION, SUCTION AND IRRIGATION
K882956 · HBI
Vital Metrics, Inc.
General & Plastic Surgery · 21d
Cleared Aug 03, 1988
AUTO SUTURE DISP. ENDOSCOPIC SURG. CLIP APPLIER
K883018 · FZP
United States Surgical, A Division of...
General & Plastic Surgery · 15d
Cleared Aug 03, 1988
STORZ MICROSURGICAL BIPOLAR COAGULATOR
K883060 · GEI
Storz Instrument Co.
General & Plastic Surgery · 15d