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
129769–129792 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 09, 1989
ORTHODERM CONVERTIBLE
K894353 · IOQ
Health Products, Inc.
Physical Medicine · 26d
Cleared Aug 09, 1989
MODIFIED LABEL TO PERCU. INTRO. W/SIDEPORT & 3-WAY
K894430 · DYB
Daig Corp.
Cardiovascular · 23d
Cleared Aug 09, 1989
KRR GLOVE, PATIENT EXAMINATION GLOVES
K894452 · LYY
Kerala Rubber & Reclaims, Ltd.
General Hospital · 51d
Cleared Aug 09, 1989
B1 FOOTSWITCH (SINGLE PEDDLE), B2 (DOUBLE PEDDLE)
K894602 · GEI
Beacon Laboratories, Inc.
General & Plastic Surgery · 20d
Cleared Aug 08, 1989
EXTENDED COVERS, STERILE
K892069 · FFF
Amedic USA
Gastroenterology & Urology · 130d
Cleared Aug 08, 1989
GENERAL (BIOPSY) NEEDLE GUIDE KIT, STERILE
K892071 · KNW
Amedic USA
Gastroenterology & Urology · 130d
Cleared Aug 08, 1989
ODIS - OBSTETRICAL DISPLAY INFO SYSTEM, HP M1370A
K892354 · HGM
Hewlett-Packard Co.
Obstetrics & Gynecology · 151d
Cleared Aug 08, 1989
ASTRO BEHIND-THE-EAR HEARING AID
K892898 · ESD
Rexton, Inc.
Ear, Nose, Throat · 110d
Cleared Aug 08, 1989
GLASS MERCURY FILLED THERMOMETERS
K893602 · FLK
Smith & Nephew United, Inc.
General Hospital · 85d
Cleared Aug 08, 1989
FD 400 DENTAL STOOL
K893946 · KLC
Oriola OY Finndent
Dental · 69d
Cleared Aug 07, 1989
PREEMICARE SERIES 2000 INFANT WARMER
K885350 · FMT
Preemicare Corp.
General Hospital · 222d
Cleared Aug 07, 1989
RESUBMITTED STC SERIES 8600 AUTOCLAVE
K890359 · FLE
Sterilizer Technologies Corp.
General Hospital · 194d
Cleared Aug 07, 1989
GAS-VAK(R), MODEL 300
K890438 · CBN
Gas-Vak
Anesthesiology · 188d
Cleared Aug 07, 1989
CARDIAC COMPUTATION SOFTWARE PACKAGE
K890636 · JOP
Elscint, Inc.
Cardiovascular · 180d
Cleared Aug 07, 1989
VOLUME COMPUTATION SOFTWARE PACKAGE
K890638 · JOP
Elscint, Inc.
Cardiovascular · 180d
Cleared Aug 07, 1989
SEALING TAPE, STERILIZATION INDICATOR
K890755 · JOJ
Spsmedical Supply Corp.
General Hospital · 174d
Cleared Aug 07, 1989
C-VAPOR STERILIZATION INDICATOR, CHEMICAL VAPOR
K890757 · JOJ
Spsmedical Supply Corp.
General Hospital · 174d
Cleared Aug 07, 1989
DRY HEAT STERILIZATION INDICATOR TAPE
K890758 · JOJ
Spsmedical Supply Corp.
General Hospital · 174d
Cleared Aug 07, 1989
STRIP, STERILIZATION INDICATOR
K890759 · JOJ
Spsmedical Supply Corp.
General Hospital · 174d
Cleared Aug 07, 1989
STRIP, STERILIZATION INDICATOR, E.O. GAS
K890760 · JOJ
Spsmedical Supply Corp.
General Hospital · 174d
Cleared Aug 07, 1989
STRIP, STERILIZATION INDICATOR
K890761 · JOJ
Spsmedical Supply Corp.
General Hospital · 174d
Cleared Aug 07, 1989
LABEL, STERILIZATION INDICATOR
K890763 · JOJ
Spsmedical Supply Corp.
General Hospital · 174d
Cleared Aug 07, 1989
LABEL, STERILIZATION INDICATOR
K890764 · JOJ
Spsmedical Supply Corp.
General Hospital · 174d
Cleared Aug 07, 1989
STRIP, STERILIZATION INDICATOR
K890765 · JOJ
Spsmedical Supply Corp.
General Hospital · 174d