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
139153–139176 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 26, 1987
AMERICAN PHARMASEAL WOUND DRESSING
K871770 · FRO
American Pharmaseal Div. Ahsc
General & Plastic Surgery · 51d
Cleared Jun 26, 1987
HOT/ICE DUAL FUNCTION EQUIPMENT
K871962 · ILO
Thermo Temp, Inc.
Physical Medicine · 37d
Cleared Jun 26, 1987
HOT/ICE DISPOSABLE BLANKET
K871963 · ILO
Thermo Temp, Inc.
Physical Medicine · 37d
Cleared Jun 26, 1987
ELASTO-GEL OCCLUSIVE DRESSING
K872165 · FRO
Southwest Technologies, Inc.
General & Plastic Surgery · 21d
Cleared Jun 26, 1987
MODIFIED OMEGA COMPRESSION HIP SCREW SYSTEM
K872223 · KTT
Howmedica Corp.
Orthopedic · 17d
Cleared Jun 26, 1987
VARIOUS SIZES & STYLES OF MONOPOLAR FORCEPS
K872271 · GEN
New England Surgical Instrument Corp.
General & Plastic Surgery · 14d
Cleared Jun 25, 1987
SUBCLAVIAN, GISH MODEL NO. SVAC-XXXX
K863791 · DQY
Gish Biomedical, Inc.
Cardiovascular · 272d
Cleared Jun 25, 1987
THE GRIPPER(TM) PORT-A-CATH NEEDLES
K870866 · FPA
Pharmacia, Inc.
General Hospital · 114d
Cleared Jun 25, 1987
HUNTLEIGH FLOWPAC FP2000
K871272 · DRM
Huntleigh Technology, Inc.
Cardiovascular · 86d
Cleared Jun 25, 1987
EBNA ACIF ASSAY KIT
K871298 · LLM
Granbio, Inc.
Microbiology · 86d
Cleared Jun 25, 1987
EBV-CHECK(TM) TEST KIT (IGG)
K871373 · GNP
Diagnostic Technology, Inc.
Microbiology · 79d
Cleared Jun 25, 1987
MODEL HP (OR MODEL 1001) TRANSCUTANEOUS STIMULATOR
K871666 · GZJ
Oriental Medical Supplies, Inc.
Neurology · 58d
Cleared Jun 25, 1987
TX-3(TENS)
K871699 · GZJ
Oms Medico, Inc.
Neurology · 55d
Cleared Jun 25, 1987
POROCOAT MARK II TOTAL ELBOW
K872084 · JDC
Depuy, Inc.
Orthopedic · 27d
Cleared Jun 25, 1987
HAMACHER BULLET POINT OPHTHALMIC NEEDLE
K872200 · HMX
R. J. Doyle, Inc.
Ophthalmic · 17d
Cleared Jun 25, 1987
COOL SHADES
K872218 · HQY
Mattel, Inc.
Ophthalmic · 16d
Cleared Jun 24, 1987
MODEL 600 VASCULAR DUPLEX IMAGER
K863589 · DXK
Multigon Industries, Inc.
Cardiovascular · 282d
Cleared Jun 24, 1987
J-CATH, GISH MODEL NO. JVAC-XXXX
K863790 · DQY
Gish Biomedical, Inc.
Cardiovascular · 271d
Cleared Jun 24, 1987
PULSE/B.P. MONITOR
K864411 · DXN
Pulse Time Products, Ltd.
Cardiovascular · 229d
Cleared Jun 24, 1987
JUDD URETHAL CATHETER CONTAINER
K864592 · KOD
Phil Judd, Inc.
Gastroenterology & Urology · 215d
Cleared Jun 24, 1987
CATHETER INTRODUCER
K871153 · DYB
Angeion Corp.
Cardiovascular · 92d
Cleared Jun 24, 1987
NORFOLK MEDICAL NORPORT
K871209 · LJT
Norfolk Medical Products, Inc.
General Hospital · 91d
Cleared Jun 24, 1987
DENTI-TRAY(TM)
K871493 · EKW
Advanced Medical, Inc.
Dental · 69d
Cleared Jun 24, 1987
STAT-PAD (TM)
K871538 · DRO
Cardiac Resucitator Corp.
Cardiovascular · 65d