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
120121–120144 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 22, 1991
DANBY-DCR VOLUMETRIC INFUSION PUMP
K912914 · FRN
Danby Medical , Ltd.
General Hospital · 50d
Cleared Aug 22, 1991
MODEL 4220
K913134 · DXY
Pace Medical
Cardiovascular · 37d
Cleared Aug 22, 1991
EMS/400
K913272 · IPF
Altoona Medical Supply
Physical Medicine · 30d
Cleared Aug 21, 1991
ALGINATE FIBER
K905040 · FRO
Shepherd Medical Corp.
General & Plastic Surgery · 288d
Cleared Aug 21, 1991
INTRAORAL DENTAL WAX
K910676 · EGD
Pemaco, Inc.
Dental · 187d
Cleared Aug 21, 1991
LANDERS WIDE FIELD TEMPORARY KERATOPROSTHESIS
K910828 · MLP
Ocular Instruments, Inc.
Ophthalmic · 175d
Cleared Aug 21, 1991
OSTEOMED SBF SYSTEM (SBF)
K911936 · DZL
Osteomed Corp.
Dental · 112d
Cleared Aug 21, 1991
MICROSURGE LASER FIBER HOLDER
K912332 · GEX
Microsurge, Inc.
General & Plastic Surgery · 89d
Cleared Aug 21, 1991
UHMWP ACETABULAR COMPONENT
K912426 · JDI
Howmedica Corp.
Orthopedic · 82d
Cleared Aug 21, 1991
STAR*SHADES(TM) SUNGLASSES
K912608 · HQY
Nalpac , Ltd.
Ophthalmic · 70d
Cleared Aug 21, 1991
MATRX, PYRAMID TRIANGLE BANDAGE
K912661 · ILI
Matrix Medica, Inc.
Physical Medicine · 64d
Cleared Aug 21, 1991
POLYESTER RESIN HAND MOLDED TRAY
K912820 · EBH
E&D Dental Products, Inc.
Dental · 57d
Cleared Aug 21, 1991
MODEL SCR-1000
K913400 · DXH
Accucore, Inc.
Cardiovascular · 22d
Cleared Aug 20, 1991
DRAINAGE CATHETERS W/A DISSOLVABLE TIP
K900205 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 581d
Cleared Aug 20, 1991
NOZOVENT, NASAL DILATOR
K904290 · LWF
Wpm Intl AB Intl Trade & Managemet...
Ear, Nose, Throat · 337d
Cleared Aug 20, 1991
SYNECTICS LIBERTY SYSTEM, PC POLYGRAF AND POLYGRAM
K904625 · BZG
Synectics-Dantec
Anesthesiology · 314d
Cleared Aug 20, 1991
SCREW, BONE, MAXILLOFACIAL
K911165 · DZL
Tekno-Medical
Dental · 158d
Cleared Aug 20, 1991
L-LINEX-RAY FLUORESCENCE
K911749 · JAO
Montifore Medical Center
Radiology · 124d
Cleared Aug 20, 1991
MINIMAX (TM) HARDSHELL VENOUS RES W/INTE CARD FILT
K911789 · DTP
Medtronic Vascular
Cardiovascular · 120d
Cleared Aug 20, 1991
SILON(TM) TRANSPARENT WOUND DRESSING
K912032 · MGP
Bio Med Sciences, Inc.
General & Plastic Surgery · 104d
Cleared Aug 20, 1991
HEART CATH TRAY
K912052 · FSM
Medical Device Inspection Co., Inc.
General & Plastic Surgery · 103d
Cleared Aug 20, 1991
SARNS SM03 MEMBRANE OXYGENATOR, MODIFICATION
K912078 · DTZ
3M Health Care, Sarns
Cardiovascular · 102d
Cleared Aug 20, 1991
SKIN SAVER(TM) TUBING HOLDER, MODEL 467
K912197 · CAT
Alpine Specialties, Inc.
Anesthesiology · 95d
Cleared Aug 20, 1991
MODIFICATION AXIOM TOTAL KNEE SYST, PATELLAR COMP
K912266 · JWH
Orothmet, Inc.
Orthopedic · 90d