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
106057–106080 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 19, 1994
LATEX EXAM GLOVES
K941787 · LYY
P.T. Irama Dinamika Latex
General Hospital · 191d
Cleared Oct 19, 1994
NEUROLOGY ACCESSORIES - MARK-EASY 10-20
K942461 · GXY
Optimit USA, Inc.
Neurology · 148d
Cleared Oct 19, 1994
AIMS CANNULATED ACL SCREW
K943539 · HWC
Smith & Nephew, Inc.
Orthopedic · 89d
Cleared Oct 19, 1994
MEDICAL SUPPORT STOCKINGS 2001/2002
K943734 · DWL
Julius Zorn, Inc.
General Hospital · 78d
Cleared Oct 19, 1994
ALSA-KLENZ
K944494 · FLG
Calgon Vestal Div.
General Hospital · 36d
Cleared Oct 19, 1994
PASCO MIC AND MIC/ID PANELS
K944517 · JWY
Pasco Laboratories, Inc.
Microbiology · 34d
Cleared Oct 19, 1994
SERIES 600 CENTRIFUGE-FOUR SEPARATE VARIATIONS OF THE SAME BASE CENTRIFUGE
K944738 · JQC
Ducker CL
Chemistry · 23d
Cleared Oct 19, 1994
CHROMOPHARE
K944855 · FSY
Berchtold Holding GmbH
General & Plastic Surgery · 19d
Cleared Oct 18, 1994
CONCHATHERM IV HEATED MOLECULAR HUMIDIFIER
K923946 · BTT
Hudson Respiratory Care, Inc.
Anesthesiology · 804d
Cleared Oct 18, 1994
AXIOM TOTAL KNEE SYST/ACL RETAIN TIBIAL TRAY/INSER
K926334 · JWH
Orthomet, Inc.
Orthopedic · 671d
Cleared Oct 18, 1994
POWERCHARGER
K934016 · DTE
Zoll Medical Corp
Cardiovascular · 426d
Cleared Oct 18, 1994
NASCOR IGLOO
K935126 · BYL
Nascor Pty. , Ltd.
Anesthesiology · 355d
Cleared Oct 18, 1994
LOCALMED INFUSION CATHETER
K935349 · KRA
Localmed, Inc.
Cardiovascular · 347d
Cleared Oct 18, 1994
FASGUIDE CATHETER
K935597 · DQY
Target Therapeutics
Cardiovascular · 333d
Cleared Oct 18, 1994
HEMOCHRON VERIGY SYSTEM/FACTOR VI QUALIFY SYSTEM
K940957 · JPA
International Technidyne Corp.
Hematology · 231d
Cleared Oct 18, 1994
OPTI-PLAST ANGIOPLASTY CATHETER
K941706 · LIT
Vas-Cath, Inc.
Cardiovascular · 195d
Cleared Oct 18, 1994
MEDTRONIC EVEREST INFLATION DEVICE
K942269 · MAV
Medtronics Interventional Vascular
Cardiovascular · 161d
Cleared Oct 18, 1994
MS CLASSIQUE BALLOON CATHETER
K942293 · LIT
Meadox Medicals, Div. Boston...
Cardiovascular · 160d
Cleared Oct 18, 1994
PROTECTAIDE PERSONAL PROTECTION PACK NO. 08315
K942470 · FXX
Protectaide, Inc.
General Hospital · 146d
Cleared Oct 18, 1994
PROTECTAIDE BIOHAZARD CLEAN-UP KIT NO. 29777
K942471 · FXX
Protectaide, Inc.
General Hospital · 146d
Cleared Oct 18, 1994
PROTECTAIDE PERSONAL PROTECTION PACK NO. 26123
K942472 · FXX
Protectaide, Inc.
General Hospital · 146d
Cleared Oct 18, 1994
PROTECTAIDE PERSONAL PROTECTION PACK NO. 24592
K942473 · FXX
Protectaide, Inc.
General Hospital · 146d
Cleared Oct 18, 1994
PROTECTAIDE PERSONAL PROTECTION PACK NO. 18000
K942474 · FXX
Protectaide, Inc.
General Hospital · 146d
Cleared Oct 18, 1994
PROTECTAIDE PERSONAL PROTECTION PACK NO. 12351
K942475 · FXX
Protectaide, Inc.
General Hospital · 146d