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
146353–146376 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 18, 1985
COMPUTED TOMOGRAPHY COUCH PAD FOR MIN ANALYSIS
K852510 · KGI
Image Analysis, Inc.
Radiology · 128d
Cleared Oct 18, 1985
5X2 SATALEC CHIROPODY CASE
K853200
Spelna, Inc.
General & Plastic Surgery · 126d
Cleared Oct 18, 1985
MOBILE OPERATING TABLE FOR ORL MICROSURGERY
K853720 · GDC
Carl Zeiss, Inc.
General & Plastic Surgery · 43d
Cleared Oct 18, 1985
HEMED NEEDLE SUPPORT CATALOG NO. HAP-XXXX
K853731 · FMI
Gish Biomedical, Inc.
General Hospital · 42d
Cleared Oct 18, 1985
REPAIR KIT QUINTON TRIPLE LUMEN RIGHT ATRIAL CATHE
K853860 · DQY
Quinton, Inc.
Cardiovascular · 31d
Cleared Oct 18, 1985
CUI RHINOPLASTY IMPLANTS
K853945 · FZE
Cox-Uphuff Intl.
General & Plastic Surgery · 24d
Cleared Oct 18, 1985
ERIKA ARTERIAL LINE 03-9837-0
K853962 · FJK
National Medical Care, Medical...
Gastroenterology & Urology · 23d
Cleared Oct 18, 1985
EROSA DISPOSABLE HYPODERMIC NEEDLE
K853980 · GAA
Rose KG
General & Plastic Surgery · 21d
Cleared Oct 18, 1985
STERILE SOFT TISSUE BIOPSY NEEDLE
K854003 · GEE
Co-Medical, Inc.
General & Plastic Surgery · 18d
Cleared Oct 17, 1985
PHADEBACT CSF TEST
K844999 · GTJ
Pharmacia, Inc.
Chemistry · 295d
Cleared Oct 17, 1985
ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER
K850884 · FOS
Sherwood Medical Co.
General Hospital · 227d
Cleared Oct 17, 1985
GOULD DISPOSABLE TRANSDUCER & ACCESSORIES-DTX
K851486 · DRS
Gould, Inc.
Cardiovascular · 185d
Cleared Oct 17, 1985
VIAL VENT FILTER
K852467 · LHI
Baxter Healthcare Corp
General Hospital · 129d
Cleared Oct 17, 1985
E-Z P.E.G. W/PERCUTANEOUS ENDOSCOPY GASTROSTOMY
K852535 · KNT
Tri-Med Specialties, Inc.
Gastroenterology & Urology · 125d
Cleared Oct 17, 1985
COONS GASTROSTICK SYSTEM
K852552 · KNT
Medi-Tech, Inc.
Gastroenterology & Urology · 122d
Cleared Oct 17, 1985
LABORIE URODYNAMICS PROCESSOR
K852856 · FAP
Tridak Division of Indicon, Inc.
Gastroenterology & Urology · 104d
Cleared Oct 17, 1985
VIROGEN HERPES SLIDE TEST
K852928 · GQO
Armkel, LLC
Microbiology · 100d
Cleared Oct 17, 1985
SARNS EVACUPLEGE CATHETER
K853128 · DWF
3M Health Care, Sarns
Cardiovascular · 83d
Cleared Oct 17, 1985
INTERNATIONAL MODEL SC CANAL IN THE EAR HEARING AI
K853172 · ESD
Int'L Hearing Aids, Inc.
Ear, Nose, Throat · 79d
Cleared Oct 17, 1985
AMERICAN DILATATION SYSTEM
K853274 · KNQ
American Endoscopy, Inc.
Gastroenterology & Urology · 73d
Cleared Oct 17, 1985
HUBOUT
K853287 · FPA
I M, Inc.
General Hospital · 73d
Cleared Oct 17, 1985
OHMEDA HEAT REFLECTING PATCH
K853351 · FMT
Ohmeda Medical
General Hospital · 66d
Cleared Oct 17, 1985
VELCRO FISTULA PRESSURE CLAMPS
K853536 · KXM
Cp Medical
Gastroenterology & Urology · 55d
Cleared Oct 17, 1985
JELCO & CATHLON IV STRIPED IV CATHETERS-RADIOPAGUL
K853701 · FOZ
Critikon Company, LLC
General Hospital · 43d