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
146785–146808 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 13, 1985
PRECEPT TM MOXALACTAM
K853689 · LTW
Austin Biological Laboratories
Microbiology · 196d
Cleared Sep 12, 1985
NORELCO ELECTRONIC DIGITAL BP METER HC3501
K852128 · DXN
Philips Park
Cardiovascular · 120d
Cleared Sep 12, 1985
ORTHO DNA PROBE HSV CONFIRMATION TEST
K852360 · GQL
Ortho Diagnostic Systems, Inc.
Microbiology · 100d
Cleared Sep 12, 1985
MODEL 78560A CENTRAL STATION PATIENT INFO SYS
K852514 · DSI
Hewlett-Packard Co.
Cardiovascular · 92d
Cleared Sep 12, 1985
EXTERNAL PACEMAKER TELECTRONICS TE200
K852746 · JOQ
Seamed Corp.
Cardiovascular · 77d
Cleared Sep 12, 1985
TRIOS - M
K853057 · DXY
Biotronik Sales, Inc.
Cardiovascular · 55d
Cleared Sep 12, 1985
IMPLANT PROGRAM CARDIAC PULSE GEN W/MOD SET SCREW
K853206 · DXY
Telectronics, Inc.
Cardiovascular · 43d
Cleared Sep 12, 1985
PHARM 100% SILICONE FOLEY CATH TEMPERATURE PROBE
K853207 · KOD
American Pharmaseal Div. Ahsc
Gastroenterology & Urology · 43d
Cleared Sep 12, 1985
ARGON CUT BIOPSY NEEDLES, VARIOUS SIZES
K853312 · DWO
Argon Medical Corp.
General & Plastic Surgery · 36d
Cleared Sep 12, 1985
SPR 2 AUTODILUTER
K853380 · JTC
Scientific Sales Intl., Inc.
Microbiology · 31d
Cleared Sep 12, 1985
SKYTRON ELITE 6000 & 6001 SURGICAL TABLES
K853480 · GDC
Skytron, Div. the Kmw Group, Inc.
General & Plastic Surgery · 23d
Cleared Sep 12, 1985
OLYMPUS RIGID PERCUTANEOUS NEPHROSCOPE
K853486 · FGA
Olympus Corp.
Gastroenterology & Urology · 23d
Cleared Sep 12, 1985
MINIFILTER HEMOFILTER
K853510 · KDI
Amicon, Inc.
Gastroenterology & Urology · 22d
Cleared Sep 12, 1985
VELCRO TOURNIQUET
K853537 · GAX
Cp Medical
General & Plastic Surgery · 20d
Cleared Sep 12, 1985
CANNULA CLAMP
K853538 · HXD
Cp Medical
General & Plastic Surgery · 20d
Cleared Sep 12, 1985
APL TRYPTIC SOY BROTH
K853609 · JSD
Apl Medical Supplies
Microbiology · 14d
Cleared Sep 12, 1985
APL XYLOSE LYSINE DEOXYCHOLATE AGAR
K853611 · JSI
Apl Medical Supplies
Microbiology · 14d
Cleared Sep 11, 1985
GRECO-HARVEY SURFACTANT BONDED CATHETER FOR GASTRO
K851242 · FGE
Cook, Inc.
Gastroenterology & Urology · 197d
Cleared Sep 11, 1985
VSM-5
K852322 · DPS
Physio-Control Corp.
Cardiovascular · 104d
Cleared Sep 11, 1985
ACUFEX COMPARATIVE SURGICAL KERATOMETER
K852424 · HJB
Acufex Microsurgical, Inc.
Ophthalmic · 96d
Cleared Sep 11, 1985
VISITEC IRRIGATION CONTROL SYSTEM
K853243 · KYG
Visitec Co.
Ophthalmic · 41d
Cleared Sep 11, 1985
SIMPLEX ENHANCEMENT MIXER
K853310 · JDZ
Howmedica Corp.
Orthopedic · 35d
Cleared Sep 11, 1985
BEAR NICU-1
K853346 · BZK
Bear Medical Systems, Inc.
Anesthesiology · 30d
Cleared Sep 11, 1985
H-H UNITIZED STANDARD SHUNT/RESERVOIR SHUNT
K853366 · JXG
Holter-Hausner Intl.
Neurology · 30d