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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
150505–150528 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 19, 1984
DOCUMENTOR
K842715 · DSI
Life Technology
Cardiovascular · 130d
Cleared Nov 19, 1984
FACTOR IX DEFICIENT PLASMA, B9D -
K843215 · GGP
Sigma Chemical Co.
Hematology · 96d
Cleared Nov 19, 1984
FACTOR X DEFICIENT PLASMA, BLOD HUMAN
K843310 · GGP
Sigma Chemical Co.
Hematology · 88d
Cleared Nov 19, 1984
LENSKEEPER LENS CARRYING CASE
K843342 · HPX
Allergan Pharmaceuticals, Inc.
Ophthalmic · 84d
Cleared Nov 19, 1984
EPISCLERAL VENOUS PRESSURE
K843354 · HKX
Eyetech, LLC
Ophthalmic · 84d
Cleared Nov 19, 1984
HEART-AID MODEL 80
K843358 · DRO
Cardiac Resucitator Corp.
Cardiovascular · 84d
Cleared Nov 19, 1984
FACTOR XI DEFICIENT PLASMA B11D
K843438 · GGP
Sigma Chemical Co.
Hematology · 76d
Cleared Nov 19, 1984
FACTOR XII DEFICIENT PLASMA B12D
K843451 · GGP
Sigma Chemical Co.
Hematology · 75d
Cleared Nov 19, 1984
PHARMA-PLAST OXYGEN CATHETER
K843466 · BZB
Zimmar Consulting , Ltd.
Anesthesiology · 74d
Cleared Nov 19, 1984
PHARMA-PLAST NASAL OXYGEN CANNULA
K843467 · CAT
Zimmar Consulting , Ltd.
Anesthesiology · 74d
Cleared Nov 19, 1984
PHARMA-PLAST SUCTION TIP, TYPE ORTHOPAE-
K843469 · JOL
Zimmar Consulting , Ltd.
General Hospital · 74d
Cleared Nov 19, 1984
SCISSORS GENERAL HOSPITAL
K844063
I M, Inc.
General & Plastic Surgery · 32d
Cleared Nov 19, 1984
SEERAM BLADE
K844073
Seeram Products Development
General & Plastic Surgery · 31d
Cleared Nov 19, 1984
WET DRESSING SALINE-STERILE
K844096 · FRO
Absorbent Cotton Co., Inc.
General & Plastic Surgery · 27d
Cleared Nov 19, 1984
XTRACETEZE SURGICAL SKIN STAPLE REMOVER 2001
K844110 · PYE
Pelco, Inc.
General & Plastic Surgery · 27d
Cleared Nov 19, 1984
STRATUS FERRITIN FLUOROMETRIC ENZYME IMMUNOASSAY
K844158 · DBF
American Dade
Immunology · 26d
Cleared Nov 19, 1984
NEC-KRADLE BY VENCOR
K844239 · HST
Vencor
Neurology · 18d
Cleared Nov 19, 1984
FLASH GUARD PLASTIC VERSION
K844286 · FSM
Sparco, Inc.
General & Plastic Surgery · 14d
Cleared Nov 19, 1984
SERIES I/S INFECTIONS
K844289 · KTN
American Dade
Immunology · 14d
Cleared Nov 16, 1984
PERSONAL CL SINGLE-CHANNEL ELECTROCAR
K842123 · DSI
Parexel Intl. Corp.
Cardiovascular · 171d
Cleared Nov 16, 1984
URITROL-M
K842808 · KNT
The Washington Group, Inc.
Gastroenterology & Urology · 121d
Cleared Nov 16, 1984
HAP ACETABULAR CUP
K843190 · JDI
Depuy, Inc.
Orthopedic · 95d
Cleared Nov 16, 1984
PHARMA-PLAST CONNECTING TUBE TYPE SUCT-
K843470 · BYY
Zimmar Consulting , Ltd.
General Hospital · 71d
Cleared Nov 16, 1984
ASN MONITOR SINGLE NEEDLE MONITOR
K843531 · KOC
Organon Teknika Corp.
Gastroenterology & Urology · 70d