FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
91801–91824 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 17, 1997
POSITIVE PRESSURE CONNECTOR
K973167 · FPA
Icu Medical, Inc.
General Hospital · 84d
Cleared Nov 17, 1997
VERSAETCH
K973257 · EBF
Centrix, Inc.
Dental · 80d
Cleared Nov 17, 1997
KETAC-FIL APLICAP PLUS
K973262 · EMA
Espe GmbH & Co. Kg.
Dental · 80d
Cleared Nov 17, 1997
CAROLINE GUIDE/DELIA LOCALIZER
K973277 · HAW
Surgical Solutions, Inc.
Neurology · 76d
Cleared Nov 17, 1997
BACT/ALERT CULTURE BOTTLES
K973305 · MDB
Organon Teknika Corp.
Microbiology · 75d
Cleared Nov 14, 1997
BONE-LOCK
K954030 · DZE
Leibinger GmbH
Dental · 809d
Cleared Nov 14, 1997
IBC CARDIAC SUCTION WARD
K963756 · DTS
International Biophysics Corp.
Cardiovascular · 423d
Cleared Nov 14, 1997
NELLCOR PURITAN BENNETT, 740 VENTILATOR SYSTEM
K964540 · CBK
Puritan Bennett Corp.
Anesthesiology · 367d
Cleared Nov 14, 1997
RESTORE (A.K.A. CAPSURE)
K971359 · MNG
Nebl, Inc.
Gastroenterology & Urology · 217d
Cleared Nov 14, 1997
SPACEMAKER SURGICALBALLOON DISSECTOR/EXPANDER
K972109 · FZW
General Surgical Innovations
General & Plastic Surgery · 162d
Cleared Nov 14, 1997
RASCAL POWER CHAIR
K972370 · ITI
Electric Mobility Corp.
Physical Medicine · 142d
Cleared Nov 14, 1997
MOST HEX INTRAMEDULLARY (I/M) STEM
K973087 · LZO
Sulzer Orthopedics, Inc.
Orthopedic · 88d
Cleared Nov 14, 1997
NPB-295 PULSE OXIMETER
K973147 · DQA
Nellcor Puritan Bennett, Inc.
Anesthesiology · 84d
Cleared Nov 14, 1997
AMERICAN DENTAL PRODUCTS HB-35 DESENSITIZER WITH FLUORIDE
K973185 · KLE
American Dental Products, Inc.
Dental · 81d
Cleared Nov 14, 1997
SYNTEC TRUE LIGHT ENDOILLUMIINATOR WITH PICK
K973290 · MPA
Vaughan Weeks
Ophthalmic · 73d
Cleared Nov 14, 1997
PASCO MIC AND MIC/ID PANELS
K973317 · LTT
Pasco Laboratories, Inc.
Microbiology · 72d
Cleared Nov 14, 1997
SENSOR PAD
K973450 · IYO
Inventive Products, Inc.
Radiology · 64d
Cleared Nov 13, 1997
TED 191
K963177 · CCL
Teledyne Brown Engineering
Anesthesiology · 456d
Cleared Nov 13, 1997
IMAGING JET SYSTEM
K970782 · JAB
General Robotic Devices, Inc.
Radiology · 254d
Cleared Nov 13, 1997
ATOMISOR
K970844 · CAF
Medical Consulting Service, Inc.
Anesthesiology · 251d
Cleared Nov 13, 1997
SERODIA TP-PA
K971502 · GMT
Scimedx Tekfile Services
Microbiology · 203d
Cleared Nov 13, 1997
IMPACT (INFORMING MOBILE PERSONNEL AND CARE TRACKING) PAGER SYSTEM
K971868 · MSX
Marquette Electronics, Inc.
Cardiovascular · 177d
Cleared Nov 13, 1997
SNT LINAC ACCESSORIES
K971893 · IYE
Surgical Navigation Technologies, Inc.
Radiology · 175d
Cleared Nov 13, 1997
CARR RIGID CONTAINER SYSTEM
K972138 · FRG
Carr Metal Products, Inc.
General Hospital · 160d