FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
130369–130392 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Aug 07, 1989
GAMMAMED 12I
K891131 · JAQ
Mick Radio-Nuclear Instruments, Inc.
Radiology · 157d
Cleared Aug 07, 1989
GERBER PRECIOUS CARE ELECTRIC BREAST PUMP
K891996 · HGX
Gerber Products Co.
Obstetrics & Gynecology · 132d
Cleared Aug 07, 1989
MEDTRONIC MODEL 3530 PERCUTANEOUS EXTENSION
K892884 · GZB
Medtronic Vascular
Neurology · 110d
Cleared Aug 07, 1989
VECSEI EXPANDING SCREW
K892925 · HWC
Howmedica Corp.
Orthopedic · 108d
Cleared Aug 07, 1989
MATRX DENTAL UNIT
K893219 · EIA
Matrix Medica, Inc.
Dental · 102d
Cleared Aug 07, 1989
CT SYTEC 3000
K893820 · JAK
General Electric Co.
Radiology · 76d
Cleared Aug 07, 1989
HOOD PEDIATRIC TRACHEOSTOMY TUBE
K893866 · BTO
Hood Laboratories
Anesthesiology · 73d
Cleared Aug 07, 1989
CONTINUOUS EPIDURAL ANESTHESIA TRAY
K893938 · CAZ
Medsurg Industries, Inc.
Anesthesiology · 68d
Cleared Aug 07, 1989
#157 EXAM LIGHT
K893949 · KFK
Medmark, Inc.
General & Plastic Surgery · 67d
Cleared Aug 07, 1989
LATEX EXAMINATION GLOVES
K894014 · LYY
Hsin Hung Co. , Ltd.
General Hospital · 62d