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.

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

Filters: Cleared only ×
175,230 results
44185–44208 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 30, 2012
CERAMIC PRODUCTS MADE IN YTTRIA-STABILIZED ZIRCONIA
K113431 · EIH
Bettini S.P.A.
Dental · 130d
Cleared Mar 30, 2012
SIMPLE T NASAL MASK
K120145 · BZD
Respironics, Inc.
Anesthesiology · 72d
Cleared Mar 30, 2012
ETCH-RITE SUPREME
K120213 · KLE
Pulpdent Corporation
Dental · 66d
Cleared Mar 30, 2012
GE ECHOPAC
K120221 · LLZ
Ge Healthcare
Radiology · 65d
Cleared Mar 30, 2012
KITTYCAT CATHETER, KITTYCAT 2 CATHETER
K120273 · PDU
Avinger, Inc.
Cardiovascular · 60d
Cleared Mar 30, 2012
PANAVIA SA CEMENT HANDMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA...
K120378 · EMA
Kuraray Medical, Inc.
Dental · 52d
Cleared Mar 30, 2012
PANAVIA SA CEMENT AUTOMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA...
K120379 · EMA
Kuraray Medical, Inc.
Dental · 52d
Cleared Mar 30, 2012
KEYPATH MRSA/MSSA BLOOD CULTURE TEST-BT
K120563 · OUS
Microphage, Inc.
Microbiology · 35d
Cleared Mar 30, 2012
ARISURE NEUTRAL VALVE
K120799 · FPA
Yukon Medical, LLC
General Hospital · 14d
Cleared Mar 29, 2012
RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM GM700
K110737 · NBW
Bionime Corporation
Chemistry · 379d
Cleared Mar 29, 2012
INFRARED EAR THEROMETER
K111703 · FLL
Fudakang Industrial Co., Ltd.
General Hospital · 286d
Cleared Mar 29, 2012
ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE...
K112538 · CHH
Alfa Wassermann Diagnostic...
Chemistry · 210d
Cleared Mar 29, 2012
IMPERIAL SURGICAL LTD. BLANKEY AND SOLUTION WARNING CABINETS
K112702 · LGZ
Imperial Surgical , Ltd.
General Hospital · 195d
Cleared Mar 29, 2012
LOCKING COMPRESSION PLATE SYSTEM
K112798 · HRS
Shanghai Microport Orthopedics Co., Ltd.
Orthopedic · 184d
Cleared Mar 29, 2012
ENTERAL ADMINISTRATION SET WITH SOLUTION CONTAINER, ENTERAL ADMINISTRATION...
K112863 · KNT
Acta Medical, LLC
Gastroenterology & Urology · 181d
Cleared Mar 29, 2012
TIGER SPINE SYSTEM
K113058 · NKB
Corelink, LLC
Orthopedic · 167d
Cleared Mar 29, 2012
POWDERED LATEX SURGICAL GLOVES STERILE, STERILE WITH PROTEIN CONTENT LABELING...
K113233 · KGO
Shen Wei (Usa), Inc.
General Hospital · 148d
Cleared Mar 29, 2012
VPAP ST-A
K113288 · MNS
Resmed, Ltd.
Anesthesiology · 143d
Cleared Mar 29, 2012
HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEM
K113327 · KTT
Stryker Corp.
Orthopedic · 140d
Cleared Mar 29, 2012
INFANT ARRAY
K113365 · MOS
Advanced Imaging Research Dba Sree...
Radiology · 135d
Cleared Mar 29, 2012
ACDS
K120005 · KPO
Isopure, Corp.
Gastroenterology & Urology · 86d
Cleared Mar 29, 2012
MCOMPASS ANORECTAL MANOMETRY SYSTEM
K120088 · KLA
Medspira, LLC
Gastroenterology & Urology · 78d
Cleared Mar 29, 2012
MEDTRONIC MINIMED PARADIGM INSULIN PUMPS
K120206 · LZG
Medtronic Minimed
General Hospital · 66d
Cleared Mar 29, 2012
FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEM
K120568 · NBW
Abbott Diabetes Care, Inc.
Chemistry · 31d