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
89449–89472 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 29, 1998
MANAN BLUNT NEEDLE
K981386 · FPA
Manan Medical Products, Inc.
General Hospital · 74d
Cleared Jun 29, 1998
QUANTECH MYOGLOBIN ASSAY
K981536 · MVE
Hellen Professional Services
Immunology · 61d
Cleared Jun 29, 1998
AST/SGOT LIQUID REAGENT - KINETIC METHOD
K981650 · CIT
Teco Diagnostics
Chemistry · 49d
Cleared Jun 29, 1998
CHOL
K981652 · CHH
Abbott Laboratories
Chemistry · 49d
Cleared Jun 29, 1998
HICHEM PHOSPHORUS REAGENT KIT
K981769 · CEO
Elan Pharma, Inc.
Chemistry · 41d
Cleared Jun 29, 1998
AST
K981843 · CIT
Abbott Laboratories
Chemistry · 34d
Cleared Jun 29, 1998
SALICYLATE-SL ASSAY CATALOGUE NUMBER 511-20,511-40
K981872 · DKJ
Diagnostic Chemicals , Ltd.
Toxicology · 32d
Cleared Jun 29, 1998
MODIFICATION FOR PTA BALLOON CATHETER
K981906 · LIT
Cook, Inc.
Cardiovascular · 28d
Cleared Jun 29, 1998
URICHEMTRAK LIQUID ASSAYED CONTROL LEVELS 1 AND 2
K981933 · JJW
Medical Analysis Systems, Inc.
Chemistry · 27d
Cleared Jun 29, 1998
OPIATES 2000 LIQUID OPIATES DRUGS OF ABUSE CONTROL LEVELS 2 AND 3
K982024 · DIF
Medical Analysis Systems, Inc.
Toxicology · 20d
Cleared Jun 29, 1998
I-STAT LACTATE TEST
K982071 · KHP
I-Stat Corp.
Chemistry · 17d
Cleared Jun 26, 1998
DIALOG DIALYSIS MACHINE
K963440 · KDI
B. Braun Medical AG
Gastroenterology & Urology · 665d
Cleared Jun 26, 1998
CORPAK MEDSYSTEMS CRUZ CATHETER FOR PERITONEAL DIALYSIS
K964514 · FKO
Corpak, Inc.
Gastroenterology & Urology · 605d
Cleared Jun 26, 1998
LIFE SUPPORT FOR TRAUMA AND TRANSPORT
K965117 · MKJ
Northrop Grumman Corp.
Cardiovascular · 553d
Cleared Jun 26, 1998
CARDIMA VUEPORT CORONARY SINUS BALLOON OCCLUSION GUIDING CATHETER
K973298 · DQY
Cardima, Inc.
Cardiovascular · 297d
Cleared Jun 26, 1998
PASSPORT 5L-CE MODEL 0998-00-0131XXX
K974178 · DRT
Datascope Corp.
Cardiovascular · 232d
Cleared Jun 26, 1998
PHYTACARE ALGINATE HYDROGEL WOUND DRESSING
K980132 · MGQ
Phytatek Laboratories, Inc.
General & Plastic Surgery · 162d
Cleared Jun 26, 1998
THALAFIX NATURAL SEA SALT DRESSING
K980779 · KMF
Dumex Medical Surgical Products, Ltd.
General & Plastic Surgery · 116d
Cleared Jun 26, 1998
RELIANCE LONG STEM FEMORAL COMPONENTS
K980813 · JDI
Howmedica, Inc.
Orthopedic · 115d
Cleared Jun 26, 1998
PATHFINDER MOBILE C ARM
K981131 · OXO
Acoma Medical Imaging, Inc.
Radiology · 88d
Cleared Jun 26, 1998
OSTEOGRAF/N-700
K981214 · LYC
Ceramed Dental, LLC
Dental · 85d
Cleared Jun 26, 1998
ALEXANDER MANUFACTURING CO. BATTERY PART NUMBER H134
K981728 · BZQ
Alexander Mfg. Co.
Anesthesiology · 42d
Cleared Jun 26, 1998
SILIMED NASAL L SHAPED IMPLANT
K981833 · FZE
Silimed, LLC
General & Plastic Surgery · 31d
Cleared Jun 26, 1998
SURGIFLATOR-20 ECU
K981859 · HIF
W.O.M. World of Medicine GmbH
Obstetrics & Gynecology · 30d