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
115537–115560 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 30, 1992
GERMAN MINI DYNALOCK
K923432 · EJF
Unitek Corp.
Dental · 109d
Cleared Oct 30, 1992
OMNIFLEX-C UHMWPE MID-SHAFT RESTRICTOR
K923616 · JDK
Osteonics Corp.
Orthopedic · 101d
Cleared Oct 30, 1992
3D IMAGING
K923823 · LNH
Resonex, Inc.
Radiology · 92d
Cleared Oct 30, 1992
ELECTROTRACE, MODIFICATION
K924133 · DRX
Jason Marketing Co.
Cardiovascular · 87d
Cleared Oct 30, 1992
CONVEEN(R) LEG BAG(500 ML)
K924406 · FAQ
Coloplast A/S
Gastroenterology & Urology · 66d
Cleared Oct 28, 1992
EUDERMIC POWDER-FREE SURGICAL GLOVES
K915807 · KGO
Bd Becton Dickinson Vacutainer...
General Hospital · 309d
Cleared Oct 28, 1992
SENSORMEDICS MODEL 2450 PULMONARY FUNCTION LAB.
K915848 · DZJ
Sensor Medics Corp.
Dental · 307d
Cleared Oct 28, 1992
120 FR OPTILUME PROSTATE BALLOON DILATOR
K920551 · KOE
American Medical Systems, Inc.
Gastroenterology & Urology · 265d
Cleared Oct 28, 1992
ASTRA T2, ASTRA T4, ASTRA T6
K920601 · DXY
Cardiac Pacemakers, Inc.
Cardiovascular · 260d
Cleared Oct 28, 1992
EVACUATOR, GASTRO-UROLOGY
K921088 · KQT
Northgate Technologies, Inc.
Gastroenterology & Urology · 236d
Cleared Oct 28, 1992
CONVERTORS STERILIZATION WRAP
K921243 · FRG
Baxter Healthcare Corp
General Hospital · 229d
Cleared Oct 28, 1992
EVACUATOR, GASTRO-UROLOGY
K921451 · KQT
Northgate Technologies, Inc.
Gastroenterology & Urology · 216d
Cleared Oct 28, 1992
FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE SYSTEM
K921690 · FAM
Vision-Sciences, Inc.
Gastroenterology & Urology · 203d
Cleared Oct 28, 1992
DEXTRON SURGICAL GLOVES
K921804 · KGO
Bd Becton Dickinson Vacutainer...
General Hospital · 196d
Cleared Oct 28, 1992
FRAY BIO-PUNCH
K921822 · MDM
Fray Products Corp.
General & Plastic Surgery · 195d
Cleared Oct 28, 1992
ENTRAC URETERAL BALLOON DILATION CATHETERS
K921839 · EZN
American Medical Systems, Inc.
Gastroenterology & Urology · 194d
Cleared Oct 28, 1992
ASI UROPLASTY LASER CYSTOSCOPE
K921990 · GEX
Advanced Surgical Intervention, Inc.
General & Plastic Surgery · 183d
Cleared Oct 28, 1992
ROYL-DERM WOUND HYDROGEL
K922815 · MGQ
Renaissance Medical, Inc.
General & Plastic Surgery · 139d
Cleared Oct 28, 1992
ZEISS VISULAS ARGON LASER
K923341 · GEX
Carl Zeiss, Inc.
General & Plastic Surgery · 145d
Cleared Oct 28, 1992
BOSTON CLEANER II
K923437 · LPN
Polymer Technology Corp.
Ophthalmic · 107d
Cleared Oct 28, 1992
AMERICAN DENTAL LASER SINGLE USE CONTACT 320 HANDP
K923539 · GEX
American Dental Laser, Inc.
General & Plastic Surgery · 104d
Cleared Oct 28, 1992
PATIENT EXAMINATION GLOVES
K923592 · LYY
Hindustan Latex , Ltd.
General Hospital · 100d
Cleared Oct 28, 1992
LIPASE HYDROLYSIS/GLYCEROT KINASE ENZYME, TRIGLYC
K924694 · CDT
Olympus Corp.
Chemistry · 42d
Cleared Oct 27, 1992
DISPOSABLE INTRAUTERINE PRESSURE TRANSDUCER
K920375 · HFN
Telos Medical Corp.
Obstetrics & Gynecology · 272d