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
149257–149280 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 12, 1985
DISPOSABLE GUEDEL AIRWAY
K850248 · CAE
Inmed Corp.
Anesthesiology · 49d
Cleared Mar 12, 1985
URETEROSCOPY CATHETER
K850335 · KOD
Inmed Corp.
Gastroenterology & Urology · 43d
Cleared Mar 12, 1985
SPECIAL PROCEDURES PACK
K850339 · FPA
Marwood Medical, Inc.
General Hospital · 43d
Cleared Mar 12, 1985
UROTRON RL9
K850348 · JJQ
Boehringer Mannheim Corp.
Chemistry · 43d
Cleared Mar 12, 1985
MENTOR PERCUTANEOUS RENAL DILATOR SET
K850355 · EZN
Mentor Corp.
Gastroenterology & Urology · 41d
Cleared Mar 12, 1985
ROTOR SYSTEMS A/S-400 & LA/S-400
K850485 · JQC
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 33d
Cleared Mar 12, 1985
SHAVE PREP TRAY
K850544 · KME
Packaging Technologies, Inc.
General Hospital · 28d
Cleared Mar 12, 1985
SECHRIST VENTILATOR/NAUTILUS CHAMBER COMBINATION
K850563 · CBF
Nautilus Environmedical Systems, Inc.
Anesthesiology · 28d
Cleared Mar 12, 1985
BSM 2000 DIALYSIS MACHINE - MODIFIED
K850569 · FKP
Organon Teknika Corp.
Gastroenterology & Urology · 28d
Cleared Mar 12, 1985
CORNING 780 FLUOROMETER/DENSITOMETER
K850617 · JQT
Corning Medical & Scientific
Chemistry · 25d
Cleared Mar 12, 1985
CARNATION OXYGEN
K850626 · BYG
Cathay Consolidated, Inc.
Anesthesiology · 21d
Cleared Mar 12, 1985
INNOFLUOR THEOPHYLLINE
K850629 · LGS
Innotron Diagnostics
Chemistry · 21d
Cleared Mar 12, 1985
HEATED RESPIRATORY HUMIFIFIER MR440
K850647 · BTT
Fisher & Paykel Allied Products , Ltd.
Anesthesiology · 21d
Cleared Mar 12, 1985
SPECTRONIC 501 & 601 - CLINICAL SPECTROPHOTOMETER
K850709 · JJQ
Bausch & Lomb, Inc.
Chemistry · 18d
Cleared Mar 11, 1985
ABSOLUTE VINYL POLYSILOXANE IMPRESS
K842877 · ELW
Coe Laboratories, Inc.
Dental · 231d
Cleared Mar 11, 1985
TRACHEAL TUBE FIXATION DEVICE
K843790 · CBH
Laerdal California, Inc.
Anesthesiology · 165d
Cleared Mar 11, 1985
EZ 505
K844162 · KIJ
Aeg Power Tool Corp.
Orthopedic · 138d
Cleared Mar 11, 1985
EZ 502
K844163 · KIJ
Aeg Power Tool Corp.
Orthopedic · 138d
Cleared Mar 11, 1985
BREAST & FOREIGN BODY LOCALIZATION INSTRUMENT
K845038 · GDF
Ranfac, Corp.
General & Plastic Surgery · 74d
Cleared Mar 11, 1985
HAM'S MIXTURE F-12 MEDIUM
K850227 · KIT
Hazleton Research Products, Inc.
Pathology · 48d
Cleared Mar 11, 1985
INTIWASH MANUAL MICROPLATE WASHER
K850371 · JTC
Inti Corp.
Microbiology · 39d
Cleared Mar 11, 1985
TRACHEOSTOMY CARE TRAY
K850445 · BTO
Paco Research Corp.
Anesthesiology · 34d
Cleared Mar 11, 1985
TRACHEOSTOMY CARE KIT
K850446 · BTO
Paco Research Corp.
Anesthesiology · 34d
Cleared Mar 11, 1985
TRACHEOSTOMY CARE KIT
K850456 · BTO
Excel Health Care Products
Anesthesiology · 33d