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
136177–136200 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 21, 1988
3M TRIMATIC M MODULAR SYSTEM AND ACCESSORIES
K880565 · IXW
3M Company
Radiology · 40d
Cleared Mar 21, 1988
MSI-PC
K880608 · GJP
Medical Specialties, Inc.
Hematology · 38d
Cleared Mar 21, 1988
RETICCOUNT SOFTWARE
K880636 · GKL
Bd Becton Dickinson Vacutainer...
Hematology · 34d
Cleared Mar 21, 1988
MASK, ANESTH. INFLATABLE & PEDIATRIC SCENTED, DISP
K880682 · BSJ
King Systems Corp.
Anesthesiology · 31d
Cleared Mar 21, 1988
DYONICS DRILL GUIDE/ISOMETER SYSTEM
K880739 · LXI
Dyonics, Inc.
Orthopedic · 26d
Cleared Mar 21, 1988
SURGICAL BURS
K880859 · GFF
New England Surgical Instrument Corp.
General & Plastic Surgery · 20d
Cleared Mar 21, 1988
MEDI-LET
K880869 · FMK
Medicore, Inc.
General & Plastic Surgery · 20d
Cleared Mar 21, 1988
MAMMOGRAPHY MOVING GRID BUCKY
K880905 · IZH
Custom Medical Products, Ltd.
Radiology · 19d
Cleared Mar 21, 1988
REPAK SURGICAL PACK (GOWN,TOWEL,MAJOR,DRAPE,BASIC)
K880942 · LRO
Repack Surgical Enterprises, Inc.
General & Plastic Surgery · 14d
Cleared Mar 21, 1988
SPRING RETRACTOR
K880997 · GAD
T. Korossurgical Instruments Corp.
General & Plastic Surgery · 13d
Cleared Mar 21, 1988
STERNUM SPREADER, PEDIATRIC
K880998 · GAD
T. Korossurgical Instruments Corp.
General & Plastic Surgery · 13d
Cleared Mar 21, 1988
KERATINOCYTE GROWTH MEDIUM (KGM)
K881000 · KIT
Clonetics Corp.
Pathology · 13d
Cleared Mar 21, 1988
AIRSTRIP* WATERPROOF FIRST AID DRESS/POST-OPERA.
K881048 · FRO
Smith & Nephew, Inc.
General & Plastic Surgery · 10d
Cleared Mar 21, 1988
SAFETY PLUS MODEL 501
K881051 · IOR
Safety Rehab Systems, Inc.
Physical Medicine · 10d
Cleared Mar 21, 1988
TITANIUM FEMORAL HIP
K881128 · JDI
Depuy, Inc.
Orthopedic · 5d
Cleared Mar 18, 1988
PC POLYGRAF
K872712 · KLA
Synectics-Dantec
Gastroenterology & Urology · 252d
Cleared Mar 18, 1988
BOND FAST NO MIX ADHESIVE
K874228 · DYH
Advanced Orthodontics Systems, Inc.
Dental · 154d
Cleared Mar 18, 1988
JEL-62
K874308 · EJT
Jelenko Co.
Dental · 150d
Cleared Mar 18, 1988
PRIME PLUS-POLYACRYLIC ACID BOND CONDITIONER
K874458 · EMA
Lustgarten Multi-Tech International,...
Dental · 141d
Cleared Mar 18, 1988
QUIDEL TOTAL IGE TEST
K875168 · DHB
Quidel Corp.
Immunology · 93d
Cleared Mar 18, 1988
DREAM DAM
K875255 · EIE
Dental Dam, Inc.
Dental · 87d
Cleared Mar 18, 1988
HERAEUS' HERAGAM 48, NON GAMMA 2 DEN. AMAL. ALLOY
K875344 · EJJ
Kulzer, Inc.
Dental · 79d
Cleared Mar 18, 1988
DEN-MAT PORETCH (PORCELAIN ETCHANT)
K875351 · ELL
Den-Mat Corp.
Dental · 78d
Cleared Mar 18, 1988
CUSTOM I.T.E. HEARING AIDS CE-5, CE-6, CE-7
K880333 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 52d