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
113185–113208 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 14, 1993
SONY CARDIAC ANALYSIS AND REVIEW STATION (CARS)
K931170 · IZI
Sony Medical Systems
Radiology · 98d
Cleared Jun 14, 1993
KENGUARD URINARY DRAINAGE BAG W/ANTIREFLUX CHAMBER
K931459 · KNX
Kendall Healthcare Products Co....
Gastroenterology & Urology · 83d
Cleared Jun 14, 1993
ELECTROPHYSIOLOGY (EP) TABLE EP 2000 SERIES
K931724 · KXJ
Continental X-Ray Corp.
Radiology · 82d
Cleared Jun 14, 1993
HEARING AIDS
K932105 · ESD
Katz Hearing Aid Center
Ear, Nose, Throat · 42d
Cleared Jun 14, 1993
IN-THE-EAR HEARING AID
K932189 · ESD
Lifestyle Hearing, Inc.
Ear, Nose, Throat · 39d
Cleared Jun 11, 1993
STERLING POWDER FREE PATIENT EXAMINATION GLOVES
K922358 · LYY
Perlink USA, Inc.
General Hospital · 388d
Cleared Jun 11, 1993
BONE LAVAGE SYSTEM
K926337 · FQH
Innovative Surgical Devices Corp.
General Hospital · 176d
Cleared Jun 11, 1993
SYNELISA RO ABS / LA ABS
K930209 · LJM
Elias U.S.A., Inc.
Immunology · 147d
Cleared Jun 11, 1993
EZ MOVER
K930324 · IYO
Prime Ideas, Inc.
Radiology · 140d
Cleared Jun 11, 1993
N-PAC STYLE C (D-STAT O.R. PROTECTIVE GOWN)
K932003 · FYA
National Healthcare Linen Service
General Hospital · 57d
Cleared Jun 10, 1993
AESCULAP MANUAL ENDOSCOPIC INSTRUMENTS
K922576 · GEI
Aesculap, Inc.
General & Plastic Surgery · 374d
Cleared Jun 10, 1993
MXR-2000 FLOWMETER
K923781 · CAX
Porter Instrument Co., Inc.
Anesthesiology · 317d
Cleared Jun 10, 1993
SIMPLA TRIDENT LEG BAG + SIMPLA S6 BAG
K925067 · KNX
Simport Plastics, Ltd.
Gastroenterology & Urology · 248d
Cleared Jun 10, 1993
MODEL 1148T TRANSVENOUS, SCREW-IN LEAD
K925347 · DTB
Siemens-Pacesetter, Inc.
Cardiovascular · 231d
Cleared Jun 10, 1993
TERUMO CORONARY GUIDE WIRE
K925852 · DQX
Terumo Medical Corp.
Cardiovascular · 205d
Cleared Jun 09, 1993
RS-1000
K911230 · KOC
Cp Medical
Gastroenterology & Urology · 812d
Cleared Jun 09, 1993
ANTI-ENDOMYSIAL ANTIBODY TEST
K912551 · DBL
Immco Diagnostics, Inc.
Immunology · 729d
Cleared Jun 09, 1993
VER MED A10011 PNS DUAL ELEMENT ELECTRODE
K921498 · BXM
Vermont Medical, Inc.
Anesthesiology · 435d
Cleared Jun 09, 1993
VARIOUS SUNGLASSES
K923374 · HQY
Playtime Products, Inc.
Ophthalmic · 335d
Cleared Jun 09, 1993
PLAYSKOOL SUNGLASSES
K923375 · HQY
Playtime Products, Inc.
Ophthalmic · 335d
Cleared Jun 09, 1993
IMAGEVIEW 46000
K925265 · LMC
Canberra Industries, Inc.
Radiology · 233d
Cleared Jun 09, 1993
AIRWAY PRESSURE MONITOR CM 5000 NGAN
K925673 · CAP
Canadian Monaghan , Ltd.
Anesthesiology · 211d
Cleared Jun 09, 1993
AFP 17 X 4 AUTOMATIC FILM PROCESSOR
K925885 · IXW
Afp Imaging Corp.
Radiology · 205d
Cleared Jun 09, 1993
ACECUT SUTOMATIC BIOPSY SYSTEM
K930201 · KNW
Meadox Surgimed, Inc.
Gastroenterology & Urology · 146d