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
137953–137976 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 19, 1987
CIBA CORNING/SHIMADZU MODEL 570 CHEM. ANALYZER
K873749 · JJE
Ciba Corning Diagnostics Corp.
Chemistry · 34d
Cleared Oct 19, 1987
COHERENT XA-30 CO2 SURGICAL LASER
K873963 · GEX
Coherent Medical Group
General & Plastic Surgery · 20d
Cleared Oct 16, 1987
NEONATAL SPUNLACE BREATHABLE POLY. FABRIC ECG(RCR)
K872871 · DRX
Labeltape Meditect, Inc.
Cardiovascular · 87d
Cleared Oct 16, 1987
EDI 320
K873599 · KQX
Cybex
Neurology · 42d
Cleared Oct 16, 1987
MAMMOGRAPHIC KVP METER MODEL 232
K873836 · IZH
Radiation Measurements, Inc.
Radiology · 25d
Cleared Oct 15, 1987
CHURCHILL PARENTERAL NUTRITION BAG - EVA
K870395 · KPE
Churchill Corp.
General Hospital · 258d
Cleared Oct 15, 1987
VIROGEN HSV ANTIBODY TEST
K871426 · GQO
Armkel, LLC
Microbiology · 189d
Cleared Oct 15, 1987
VACU-AIDE
K872094 · JCX
The Devilbiss Co.
General & Plastic Surgery · 136d
Cleared Oct 15, 1987
FIAX TEST KIT FOR LYME DISEASE ANTIBODIES
K872247 · LSR
Whittaker Bioproducts, Inc.
Microbiology · 126d
Cleared Oct 15, 1987
CHURCHILL-CATH
K872585 · FOZ
Churchill Corp.
General Hospital · 106d
Cleared Oct 15, 1987
YHLAMYDIA CF ANTIGEN AND CONTROL ANTIGEN
K872700 · GPW
Sita, Inc.
Microbiology · 100d
Cleared Oct 15, 1987
DUAL-THERMISTOR THERMODILUTION CATH. & INFU. CATH.
K872770 · DYG
Nova Medical Specialties
Cardiovascular · 93d
Cleared Oct 15, 1987
NIDEK ADC-8000 LASER SYSTEM
K872846 · HQF
Nidek, Inc.
Ophthalmic · 87d
Cleared Oct 15, 1987
WILLIAMS VERTEBRAL SPREADER
K872858 · HXP
Ace Medical Co.
Orthopedic · 86d
Cleared Oct 15, 1987
ACROMED BONE PLATE BENDER
K872949 · HXW
Buckman Co., Inc.
Orthopedic · 79d
Cleared Oct 15, 1987
W-J STERILE TRI-FUNCTIONAL CONTACT LENS SOLUTION
K872973 · LPN
Wesley Jessen Corp.
Ophthalmic · 77d
Cleared Oct 15, 1987
KEANE MOBILITY BED
K873047 · IKZ
Surgi-Med, Inc.
Physical Medicine · 72d
Cleared Oct 15, 1987
NEER-III GLENOID RESURFACING PROSTHESIS
K873104 · KWT
Kirschner Medical Corp.
Orthopedic · 69d
Cleared Oct 15, 1987
VICOR, MODEL 410A
K873202 · DXY
Tpl-Cordis, Inc.
Cardiovascular · 63d
Cleared Oct 15, 1987
IDENTICULT-BL
K873509 · JTO
Scott Laboratories, Inc.
Microbiology · 45d
Cleared Oct 15, 1987
NEER-III OSTEOARTHRITIS GLENOID RESURFACE PROSTHE.
K873620 · KWT
Kirschner Medical Corp.
Orthopedic · 37d
Cleared Oct 15, 1987
NEER-III SOLID KEEL GLENOID RESURFACING PROSTHESIS
K873621 · KWT
Kirschner Medical Corp.
Orthopedic · 37d
Cleared Oct 15, 1987
STANDARD KNIFE, DISPOSABLE #TM-1610
K873712 · HTS
Arthropedics, Inc.
Orthopedic · 30d
Cleared Oct 15, 1987
LABELING CHANGES COAT-A-COUNT METHADONE IN URINE
K873750 · DJR
Diagnostic Products Corp.
Toxicology · 41d