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
143401–143424 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 25, 1986
WRIST ACTIGRAPH
K854030 · GWQ
Ambulatory Monitoring, Inc.
Neurology · 267d
Cleared Jun 25, 1986
BARD-PARKER CAROTID SHUNT
K860136 · DWF
Bd Becton Dickinson Vacutainer...
Cardiovascular · 162d
Cleared Jun 25, 1986
DOUBLE ANTIBODY CALCITONIN RIA KIT
K861274 · JKR
Diagnostic Products Corp.
Chemistry · 79d
Cleared Jun 25, 1986
ALT-30, 60 AND 100
K861366 · CKA
Dimension Diagnostics
Chemistry · 75d
Cleared Jun 25, 1986
ASSERA-PLATE VWF KIT
K861417 · GGP
American Bioproducts Co.
Hematology · 71d
Cleared Jun 25, 1986
ASSERA-PLATE PROTEIN C KIT
K861475 · GGP
American Bioproducts Co.
Hematology · 64d
Cleared Jun 25, 1986
COMPANION LIQUID OXYGEN SYSTEM
K861503 · BYJ
Puritan Bennett Corp.
Anesthesiology · 63d
Cleared Jun 25, 1986
DIRECT BILIRUBIN PROCEDURE
K861671 · CIG
Data Medical Associates, Inc.
Chemistry · 56d
Cleared Jun 25, 1986
THEOPHYLLINE (FPIA) CALIBRATOR KIT
K861768 · JIS
Windsor Laboratories, Inc.
Toxicology · 49d
Cleared Jun 25, 1986
GENTAMICIN (FPIA) CALIBRATOR KIT
K861769 · JIS
Windsor Laboratories, Inc.
Toxicology · 49d
Cleared Jun 25, 1986
PHENYTOIN (FPIA) CALIBRATOR KIT
K861770 · JIS
Windsor Laboratories, Inc.
Toxicology · 49d
Cleared Jun 25, 1986
FITTRONIC
K861796 · IPF
Corleone Intl. Traders, Inc.
Physical Medicine · 47d
Cleared Jun 25, 1986
TOBRAMYCIN (FPIA) CALIBRATOR KIT
K861891 · JIS
Windsor Laboratories, Inc.
Toxicology · 40d
Cleared Jun 25, 1986
SCOTCHBOND LIGHT CURED DENTAL ADHESIVE W/FLUORIDE
K861899 · EBF
3M Company
Dental · 40d
Cleared Jun 25, 1986
ULTRALITE HF1236 HAND AND FOOT SYSTEM
K861963 · FTC
Ultralite
General & Plastic Surgery · 36d
Cleared Jun 25, 1986
KHURI REGIONAL TISSUE PH MONITOR
K862114 · CBZ
Vascular Technology Incorporated
Anesthesiology · 22d
Cleared Jun 25, 1986
HYGEIA RAPID STREP A TEST
K862133 · GTY
Hygeia Sciences
Microbiology · 21d
Cleared Jun 25, 1986
X-MAT
K862144 · KXJ
Combined Concepts, Inc.
Radiology · 21d
Cleared Jun 25, 1986
ALT (SGPT) REAGENT SET (UV RATE)
K862209 · CKA
Sterling Diagnostics, Inc.
Chemistry · 15d
Cleared Jun 24, 1986
S80 IMPLANTABLE CARDIAC PACING LEAD
K854963 · DTB
Sorin Biomedica, Fiat, USA, Inc.
Cardiovascular · 195d
Cleared Jun 24, 1986
DELFIA (TM) HFSH KIT
K862043 · CGJ
Lkb Instruments, Inc.
Chemistry · 27d
Cleared Jun 23, 1986
ENTERNAL INFUSER MULTIPUMP 203
K861040 · FRN
Medix Medical Electronics (U.S.A.), Inc.
General Hospital · 97d
Cleared Jun 23, 1986
UCS-2, ULTRASONIC CLEANING SOLUTION
K861147 · FLG
Keymed, Inc.
General Hospital · 89d
Cleared Jun 23, 1986
PTT AUTOMATE TEST KIT
K861190 · GGW
American Bioproducts Co.
Hematology · 84d