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
117601–117624 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 27, 1992
DISETRONIC(R) INFUSOR
K913891 · FRN
Disetronic Medical Systems
General Hospital · 210d
Cleared Mar 27, 1992
LPI ML210 HOLMIUM SURGICAL LASER, MODIFICATION
K914827 · GEX
Laser Photonics, Inc.
General & Plastic Surgery · 157d
Cleared Mar 27, 1992
FOXELL PLUS MULTIPLE(PERSONAL TOUCH), MODIFICATION
K915105 · LYY
Wah-Chang and Stone Lion
General Hospital · 135d
Cleared Mar 27, 1992
CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATH. KITS
K915215 · LFK
Akcess Medical Products, Inc.
Gastroenterology & Urology · 130d
Cleared Mar 27, 1992
CO2 LASER AND WAVEGUIDE DELIVERY SYSTEMS FOR THOR.
K915583 · GEX
Heraeus Lasersonics, Inc.
General & Plastic Surgery · 105d
Cleared Mar 27, 1992
MODIFIED BIOLOG
K915624 · DRT
Micromedical Industries, Ltd.
Cardiovascular · 113d
Cleared Mar 27, 1992
PACEVIEW
K915627 · KRB
Micromedical Industries, Ltd.
Cardiovascular · 109d
Cleared Mar 27, 1992
SEX CRIMES/SEX ASSAULT VICT/SUSPECT EVID COLL KITS
K915814 · JKA
Sirchie Finger Print Laboratories, Inc.
Chemistry · 88d
Cleared Mar 27, 1992
BITE BLOCK/MOUTHPIECE FOR ENDOSCOPY
K915816 · EOQ
Gi Supply
Ear, Nose, Throat · 88d
Cleared Mar 27, 1992
BAIR HUGGER PATIENT WARMING SYSTEM
K920265 · DWJ
Augustine Medical, Inc.
Cardiovascular · 66d
Cleared Mar 27, 1992
UNISTIK
K920562 · FMK
Ulster Scientific, Inc.
General & Plastic Surgery · 50d
Cleared Mar 27, 1992
MEDIX BIOTECH THROXINE ENZYME IMMUNOASSAY TEST KIT
K920712 · KLI
Medix Biotech, Inc.
Chemistry · 38d
Cleared Mar 27, 1992
OLYMPIC TRANS-LITE
K920782 · KYT
Olympic Medical Corp.
General Hospital · 36d
Cleared Mar 27, 1992
AMYLASE REAGENT
K921057 · JFJ
Genzyme Corp.
Chemistry · 22d
Cleared Mar 26, 1992
IMED 4100 AND 4200 DISPOSABLE INFUSION DEVICES MOD
K913658 · MEB
Imed Corp.
General Hospital · 241d
Cleared Mar 26, 1992
MYOTRAC+/S, MYODAC+/S
K913898 · HCC
Thought Technology , Ltd.
Neurology · 209d
Cleared Mar 26, 1992
SERIM DISINTEK REAGENT STRIPS
K913943 · MED
Serim Research Corp.
General Hospital · 204d
Cleared Mar 26, 1992
ORTHODONTIC BRACKET ADHESIVE RESIN MATERIAL
K914317 · DYH
Confi-Dental Products Co.
Dental · 182d
Cleared Mar 26, 1992
UNISURGE TISSUE COLLECTION SYSTEM FOR ENDOS SURG
K914922 · GCJ
Charles L. Rose and Co., Inc.
General & Plastic Surgery · 143d
Cleared Mar 26, 1992
E350I ELECTROCARDIOGRAPH
K914969 · LOS
Siemens Burdick, Inc.
Cardiovascular · 142d
Cleared Mar 26, 1992
DAVOL 100CC SILICONE CLOSED WOUND DRAINAGE EVAC
K915536 · GCY
Davol, Inc.
General & Plastic Surgery · 107d
Cleared Mar 26, 1992
HUMAN IGG SUBCLASS RID KIT
K915650 · CGM
Janssen Biochimica
Immunology · 99d
Cleared Mar 26, 1992
MULTIPLE DRESSING, STERILE NONADDHERENT PADS
K915822 · NAB
Kerma Medical Products, Inc.
General & Plastic Surgery · 87d
Cleared Mar 26, 1992
LANDMARK MIDLINE CATHETER
K920028 · FOZ
Menlo Care, Inc.
General Hospital · 83d