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
90937–90960 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 17, 1997
IL TEST AMYLASE
K974125 · JFJ
Instrumentation Laboratory CO
Chemistry · 44d
Cleared Dec 17, 1997
ALERT
K974131 · EBF
Jeneric/Pentron, Inc.
Dental · 44d
Cleared Dec 17, 1997
POWDERED NITRILE EXAMINATION GLOVES (BLUE COLOUR)
K974182 · LZA
Sri Johani Sdn. Bhd.
General Hospital · 41d
Cleared Dec 17, 1997
ELITE LIGHTWEIGHT WHEELCHAIR
K974197 · IOR
Jaken Co., Inc.
Physical Medicine · 40d
Cleared Dec 17, 1997
IL TEST UREA NITROGEN
K974337 · CDQ
Instrumentation Laboratory CO
Chemistry · 29d
Cleared Dec 17, 1997
ELECSYS CK-MB STAT
K974421 · JHY
Boehringer Mannheim Corp.
Chemistry · 23d
Cleared Dec 17, 1997
VIGIL LIPID CONTROL
K974452 · JJY
Beckman Instruments, Inc.
Chemistry · 22d
Cleared Dec 16, 1997
EXEL I.V. ADMINISTRATION SET
K963659 · FPA
Exel Intl.
General Hospital · 469d
Cleared Dec 16, 1997
BIRTHNET II PERINATAL PATIENT DATA MANAGEMENT SYSTEM
K965008 · HGM
Spacelabs Medical, Inc.
Obstetrics & Gynecology · 365d
Cleared Dec 16, 1997
STRYKER CONSTAVAC BLOOD CONSERVATION SYSTEM II (CBCII)
K970714 · CAC
Stryker Instruments
Anesthesiology · 292d
Cleared Dec 16, 1997
ARAGO
K971118 · GEX
Premier Laser Systems, Inc.
General & Plastic Surgery · 270d
Cleared Dec 16, 1997
ONE TOUCH II HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM DATA DOCK
K972473 · CGA
Lifescan, Inc.
Chemistry · 168d
Cleared Dec 16, 1997
TOF-WATCH
K972698 · KOI
Organon Teknika Corp.
Anesthesiology · 151d
Cleared Dec 16, 1997
PROTOS BLOOD TRANSFUSION SET
K972843 · BRZ
Globe Ent., Inc.
General Hospital · 137d
Cleared Dec 16, 1997
KENDALL CURITY PETROLATUM GAUZE
K973511 · FRO
Kendall Healthcare Products Co....
General & Plastic Surgery · 90d
Cleared Dec 16, 1997
MAURICE WORLDWIDE SHUNT SYSTEM
K973525 · JXG
Integra Neurocare, LLC
Neurology · 90d
Cleared Dec 16, 1997
N-TERFACE
K973538 · MGP
Winfield Laboratories, Inc.
General & Plastic Surgery · 89d
Cleared Dec 16, 1997
OCU-GUARD ORBITAL IMPLANT WRAP, SUPPLE OCU-GUARD ORBITAL IMPLANT WRAP
K973552 · MTZ
Bio-Vascular, Inc.
Ophthalmic · 88d
Cleared Dec 16, 1997
PRESTIGE AQUEOUS GLUCOSE CONTROL LOW, PRESTIGE AQUEOUS GLUCOSE CONTROL HIGH
K973676 · JJX
Sorrento Biochemical, Inc.
Chemistry · 81d
Cleared Dec 16, 1997
ULTRALON POWDER FREE LATEX SURGICAL GLOVE
K973699 · KGO
Johnson & Johnson Medical, Inc.
General Hospital · 78d
Cleared Dec 16, 1997
FLEXVIEW CO2 BLOWER WITH MIST
K973803 · FQH
Ethicon Endo-Surgery, Inc.
General Hospital · 71d
Cleared Dec 16, 1997
T-REX BIOPSY FORCEPS
K973818 · DWZ
Boston Scientific Corp
Cardiovascular · 70d
Cleared Dec 16, 1997
CAVITY VARNISH (INTERMEDIARY VARNISH AND DENTINAL TUBULI SEAL)
K973919 · LBH
Medental Intl.
Dental · 62d
Cleared Dec 16, 1997
HEARTPORT ENDOAORTIC CLAMP CATHETER
K974175 · DWZ
Heartport, Inc.
Cardiovascular · 40d