FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
86905–86928 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 04, 1999
NATURAL BRAND ACUPUNCTURE NEEDLES
K983671 · MQX
Tcm Supply Corp.
General Hospital · 136d
Cleared Mar 04, 1999
ALLISON MEDICAL INSULIN SYRINGE (AMIS)
K984017 · FMF
Allison Medical, Inc.
General Hospital · 112d
Cleared Mar 04, 1999
AARON TOP50 REUSABLE ELECTROSURGICAL PENCIL, MODEL #ESPR
K984352 · GEI
Aaron Medical Industries
General & Plastic Surgery · 90d
Cleared Mar 04, 1999
TRANSFX EXTERNAL FIXATION SYSTEM
K984357 · LXT
Immedica, Inc.
Orthopedic · 87d
Cleared Mar 04, 1999
NERVE BLOCK INFUSION KIT
K984502 · MEB
I-Flow Corp.
General Hospital · 76d
Cleared Mar 04, 1999
VIRASTAT FITC-LABELED ANTI-INFLUENZA A AND B MONOCLONAL ANTIBODIES
K984596 · GNR
Zymetx, Inc.
Microbiology · 66d
Cleared Mar 04, 1999
MONOPAQUE
K990315 · EBF
Ivoclar North America, Inc.
Dental · 31d
Cleared Mar 04, 1999
OPTICAL TRACKING SYSTEM MICROSCOPE MODULE II, MODEL OTS MMII
K990326 · HAW
Radionics Software Applications, Inc.
Neurology · 30d
Cleared Mar 04, 1999
MODIFICATION TO MULTAPORT CANNULA, REDUCER AND ACCESSORIES
K990379 · GCJ
Dexide, Inc.
General & Plastic Surgery · 24d
Cleared Mar 03, 1999
PANASONIC WRIST BLOOD PRESSURE METER, MODEL EW280
K981431 · DXN
Panasonic Corporation (Panasonic)
Cardiovascular · 317d
Cleared Mar 03, 1999
PANASONIC WRIST BLOOD PRESSURE METER, MODEL EW284
K981542 · DXN
Panasonic Corporation (Panasonic)
Cardiovascular · 308d
Cleared Mar 03, 1999
STERILE POWDER FREE NITRILE SURGEONS GLOVES (NATURAL, BLUE AND GREEN)
K981947 · KGO
Boston Medical Corp.
General Hospital · 273d
Cleared Mar 03, 1999
GUIDANT MEGALINK BILIARY STENT, MODEL #'S 1002949-18, 1002949-28, 1002949-38
K983075 · FGE
Guidant Corp.
Gastroenterology & Urology · 182d
Cleared Mar 03, 1999
D.O.R.C. HARMONY TOTAL VITRECTOMY SYSTEM
K983797 · HQE
Dutch Ophthalmic USA, Inc.
Ophthalmic · 126d
Cleared Mar 03, 1999
MEPITEL NON ADHERENT SILICONE DRESSING
K984371 · MGP
Molnlycke Health Care, Inc.
General & Plastic Surgery · 86d
Cleared Mar 03, 1999
HA ABSORBENT WOUND DRESSING
K984388 · KGN
Convatec, A Division of E.R. Squibb &...
General & Plastic Surgery · 85d
Cleared Mar 03, 1999
TOPOGRAPHIC IMAGING MARKER
K990242 · KPR
I.Z.I. Medical Products Corp.
Radiology · 37d
Cleared Mar 03, 1999
TOPOGRAPHIC IMAGING MARKER
K990298 · KPR
I.Z.I. Medical Products Corp.
Radiology · 30d
Cleared Mar 03, 1999
HYDRO-CAST DENTAL ETCHING GEL, MODEL 60025
K990306 · EBC
Kay See Dental Mfg. Co.
Dental · 30d
Cleared Mar 02, 1999
ABPM MOBIL-O-GRAPH BLOOD PRESSURE MONITOR, MODEL ABP CONTROL
K964235 · DXN
Industrielle Entwicklung...
Cardiovascular · 860d
Cleared Mar 02, 1999
PHORESOR II,MODEL PM900
K982668 · EGJ
Iomed, Inc.
Physical Medicine · 214d
Cleared Mar 02, 1999
DIDECO D920, LILLIPUT 1 TWIN RESERVOIR
K984322 · DTP
Dideco S.P.A.
Cardiovascular · 89d
Cleared Mar 02, 1999
SYNTEC-TAICHUNG NON-STERILE SMALL ORTHOPEDIC FIXATION SYSTEM, MODEL 71100,...
K984364 · KTT
Syntec Scientific Corp.
Orthopedic · 85d
Cleared Mar 02, 1999
MOSS TUBES, INC. NASAL TUBE - MARK IV
K984629 · BSS
Moss Tubes, Inc.
Gastroenterology & Urology · 62d