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
100369–100392 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 24, 1995
SIENET SPI SPOOLER
K953552 · LMD
Siemens Medical Solutions USA, Inc.
Radiology · 88d
Cleared Oct 24, 1995
LIFESHIELD LUER ACTIVATED VALVE MALE ADAPTER PLUG
K953584 · FPA
Abbott Laboratories
General Hospital · 84d
Cleared Oct 24, 1995
TYMPANOSTOMY TUBE
K953802 · ETD
Bluff City Medical Technologies, Inc.
Ear, Nose, Throat · 78d
Cleared Oct 24, 1995
EXTERNAL DRAINAGE SYSTEM (EDS AND EDS II)
K954021 · JXG
Johnson & Johnson Professionals, Inc.
Neurology · 85d
Cleared Oct 24, 1995
HDX DIGITAL IMAGING SYSTEM
K954055 · LLZ
Imacom, Inc.
Radiology · 56d
Cleared Oct 24, 1995
UNIVERSIX 120
K954196 · KPR
Philips Medical Systems (Cleveland),...
Radiology · 48d
Cleared Oct 24, 1995
MAMMOSPOT PADDLE
K954521 · IZH
American Mammographics, Inc.
Radiology · 26d
Cleared Oct 23, 1995
KSEA REVERSE VIDEO
K952482 · FET
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 146d
Cleared Oct 23, 1995
NIOMED SHOE COVERS
K952897 · FXP
Amerasia Corp.
General Hospital · 122d
Cleared Oct 23, 1995
NIOMED NON-SKID SHOE COVERS
K952937 · FXP
Amerasia Corp.
General Hospital · 119d
Cleared Oct 23, 1995
LUNAR DPX DENSITOMETER
K953032 · KGI
Lunar Corp.
Radiology · 115d
Cleared Oct 23, 1995
IRIS BILATERAL TMJ
K953248 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 104d
Cleared Oct 23, 1995
DISTENTION BALLOON
K953377 · GCJ
Origin Medsystems, Inc.
General & Plastic Surgery · 96d
Cleared Oct 23, 1995
VITALOCK SPIKED ACETABULAR SHELL
K953664 · LPH
Howmedica Corp.
Orthopedic · 77d
Cleared Oct 23, 1995
LUMITROL CONTROLLER, LUMITROL HAND-CONTROLLED ELECTROSURGICAL PENCIL WITH...
K953992 · GEI
Lmi Lightwave Medical Industries , Ltd.
General & Plastic Surgery · 60d
Cleared Oct 23, 1995
CHEMSTRIP CRITERION URINE ANALYZER
K954024 · KQO
Boehringer Mannheim Corp.
Chemistry · 56d
Cleared Oct 23, 1995
OSOM PREGNANCY TEST
K954178 · LCX
Wyntek Diagnostics, Inc.
Chemistry · 48d
Cleared Oct 23, 1995
TRIGLYCERIDES REAGENT
K954187 · JGY
Schiapparelli Biosystems, Inc.
Chemistry · 47d
Cleared Oct 23, 1995
SURGICAL DYNAMICS 30K WORKING CHANNEL SCOPE & INSTRUMENT SET
K954193 · HRX
Surgical Dynamics, Inc.
Orthopedic · 47d
Cleared Oct 23, 1995
CONTAMINATION CONTAINMENT DRAPE
K954212 · KKX
Engineering Controls For Medicine
General Hospital · 46d
Cleared Oct 23, 1995
ARTHROPLAST & ARTHRO-CUTTER
K954217 · HRX
Future Medical Systems, Inc.
Orthopedic · 45d
Cleared Oct 23, 1995
5F ENVOY GUIDING CATHETER (MODIFICATION)
K954251 · DQY
Cordis Neurovascular, Inc.
Cardiovascular · 60d
Cleared Oct 23, 1995
CENTRALITE BACKPOINTER
K954414 · IWE
Diacor, Inc.
Radiology · 32d
Cleared Oct 23, 1995
WILOMAT STERILIZABLE CLIP FORCEPS W/INTERCHANGABLE MAGAZINES
K954435 · FZP
Wilo Medizintechnik Lothar Wilberg GmbH
General & Plastic Surgery · 31d