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
112177–112200 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 25, 1993
KOMET MEDICAL SURGICAL POWER ACCESORIES
K930109 · JDX
Brassler USA
Orthopedic · 226d
Cleared Aug 25, 1993
POWDER-FREE LATEX EXAMINATION GLOVES
K930407 · LYY
Influx Pacific Sdn. Bhd.
General Hospital · 211d
Cleared Aug 25, 1993
MODISSA 90 S.R.L. SPECTACLE FRAMES
K930857 · HQZ
Modissa 90 Srl
Ophthalmic · 188d
Cleared Aug 25, 1993
PROBE PERSONAL PREFERENCE NON-STER. PAT. EXAM.GLOV
K930903 · LYY
Glove India Private , Ltd.
General Hospital · 183d
Cleared Aug 25, 1993
ECLIPSE 2100(TM) MODEL 32, MODIFICATION
K931101 · GEX
Cardiogenes
General & Plastic Surgery · 198d
Cleared Aug 25, 1993
FERNO-WASHINGTON INCUBATOR TRANSPORTER,# 29-IT
K931346 · FPL
Ferno
General Hospital · 161d
Cleared Aug 25, 1993
DENRICK SPEECH AID (DR-1)
K931371 · ESE
Denrick Corp.
Ear, Nose, Throat · 161d
Cleared Aug 25, 1993
KING SODIUM/POTASSIUM STANDARD MODIFIED
K931834 · JIS
King Diagnostics, Inc.
Chemistry · 152d
Cleared Aug 25, 1993
TRIGLYCERIDES
K931891 · CDT
Em Diagnostic Systems, Inc.
Chemistry · 132d
Cleared Aug 25, 1993
VLC DR MATERIAL
K932395 · EBF
Dentsply Intl.
Dental · 99d
Cleared Aug 25, 1993
LANGGASSE 90
K932470 · ETF
Happersberger Otopront GmbH
Ear, Nose, Throat · 97d
Cleared Aug 25, 1993
MARK I HUMIDIFIER
K932570 · BTT
C.F. Electronics, Inc.
Anesthesiology · 90d
Cleared Aug 25, 1993
RADIAS B12 ENZYME IMMUNOASSAY
K933315 · CDD
Bio-Rad
Chemistry · 49d
Cleared Aug 25, 1993
INSUFFLATOR TUBING KIT W/FILTER
K933661 · GCJ
Eagle Medical, Inc.
General & Plastic Surgery · 29d
Cleared Aug 24, 1993
VASCOSCREW 6/60 AND VASCOSCREW 8/60
K914121 · DTB
Vascor Medical Corp.
Cardiovascular · 711d
Cleared Aug 24, 1993
INTERFERENCE-CANNU-FLEX/SILK SCREWS-SCREW DR/G WIR
K921481 · HWC
Acufex Microsurgical, Inc.
Orthopedic · 512d
Cleared Aug 24, 1993
MINVASIVE SUTURE BONE FASTENER
K924034 · JDR
Innovasive Devices, Inc.
Orthopedic · 378d
Cleared Aug 24, 1993
CLARUS ENDOSCOPIC HOOK KNIFE
K925741 · HLX
Clarus Medical Systems, Inc.
Ophthalmic · 284d
Cleared Aug 24, 1993
LACEY REVISION FEMORAL COMPONENT
K925900 · JWH
Dow Corning Wright
Orthopedic · 277d
Cleared Aug 24, 1993
MEDCAM
K925967 · EIA
Medcam USA, Inc.
Dental · 272d
Cleared Aug 24, 1993
MEDTRONIC ARTERIAL FILTER
K926413 · DTM
Medtronic Vascular
Cardiovascular · 244d
Cleared Aug 24, 1993
L.C.S.3000
K926464 · GEH
Cryodyne Technologies, Inc.
General & Plastic Surgery · 243d
Cleared Aug 24, 1993
LATEX EXAMINATION GLOVES (POWDER FREE)
K926526 · LYY
Rantran, Inc.
General Hospital · 237d
Cleared Aug 24, 1993
HYPO-ALLERGENIC PATIENT EXAMINATION GLOVES
K930139 · LYY
Shun Thai Rubber Gloves Industry Co.,...
General Hospital · 224d