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
91441–91464 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 17, 1997
POWDERFREE NITRILE EXAMINATION GLOVES (BLUE COLOUR)
K973903 · LZA
Sri Johani Sdn. Bhd.
General Hospital · 64d
Cleared Dec 17, 1997
POLYMER LATEX EXAMINATION GLOVES
K973904 · LYY
Sri Johani Sdn. Bhd.
General Hospital · 64d
Cleared Dec 17, 1997
DBEST ONE-STEP HCG SERUM/URINE TEST
K973957 · JHI
Ameritek, Inc.
Chemistry · 62d
Cleared Dec 17, 1997
3M DENT SYSTEM II PLUS
K973961 · EMA
3M Company
Dental · 62d
Cleared Dec 17, 1997
EXTENSION SET WITH MICROBORE TUBING, EXTENSION SET WITH MICROBORE TUBING AND...
K974013 · FPA
Sims Deltec, Inc.
General Hospital · 56d
Cleared Dec 17, 1997
PULPDENT DENTASTIC UNO
K974014 · EMA
Pulpdent Corp.
Dental · 56d
Cleared Dec 17, 1997
CENTURY ALLOY
K974035 · EJJ
Dentsply Intl.
Dental · 54d
Cleared Dec 17, 1997
ALLOY PRIMER
K974089 · KLE
Kuraray America, Inc.
Dental · 49d
Cleared Dec 17, 1997
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K974120 · LYZ
Shanghai Super Gloves Co., Ltd.
General Hospital · 47d
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