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
148561–148584 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 02, 1985
QUICKIE WHEELCHAIRS
K850536 · IOR
Motion Designs, Inc.
Physical Medicine · 80d
Cleared May 02, 1985
CO-AX VENTILATOR CIRCUIT
K850600 · BZO
Nova-Ventrx
Anesthesiology · 76d
Cleared May 02, 1985
PM CEMENTLESS SCREW-IN ACETABULAR CUP
K850773 · KWA
Advanced Biosearch Assn.
Orthopedic · 66d
Cleared May 02, 1985
TRACHEOBRONCHIAL SUCTION KITS W/CATHETERS ETO
K850864 · BSY
Paco Research Corp.
Anesthesiology · 62d
Cleared May 02, 1985
COBAS MIRA
K851172 · JJF
Roche Diagnostic Systems, Inc.
Chemistry · 41d
Cleared May 02, 1985
COLUMBIZ CNA AGAR W/5% SHEEP BLOOD
K851580 · JSJ
Preferred Micro-Media
Microbiology · 16d
Cleared May 02, 1985
DERMATOPHYTE TEST MEDIUM
K851581 · JSI
Preferred Micro-Media
Microbiology · 16d
Cleared May 02, 1985
GN BROTH
K851582 · JSJ
Preferred Micro-Media
Microbiology · 16d
Cleared May 02, 1985
HEKTOEN ENTERIC AGAR
K851583 · JSI
Preferred Micro-Media
Microbiology · 16d
Cleared May 01, 1985
ESCOTEK EST TRAC 401
K844385 · ITH
Nor-Am Patient Care Products, Inc.
Physical Medicine · 169d
Cleared May 01, 1985
ESCOTEK-EST 301A ULTRA-SONIC UNIT
K844386 · IMI
Nor-Am Patient Care Products, Inc.
Physical Medicine · 169d
Cleared May 01, 1985
SURGICRAFT COPELAND DISPOSABLE
K844608 · HGP
A.W. Showell (Surgicraft) , Ltd.
Obstetrics & Gynecology · 155d
Cleared May 01, 1985
FETAL TELEMETRY SYSTEM
K844724 · HGM
Advantage Medical Systems, Inc.
Obstetrics & Gynecology · 148d
Cleared May 01, 1985
ABDOMINAL PRESSURE CONTROL VALVE
K844829 · HHR
L.A.S.E.R., Inc.
Obstetrics & Gynecology · 140d
Cleared May 01, 1985
CORDIS DUAL-CHAMBER PSA MODEL 296A (PACEMAKER)
K844969 · DTC
Cordis Corp.
Cardiovascular · 128d
Cleared May 01, 1985
SUN MEDICAL LAMINARIA CERVICAL DILATOR
K845006 · HDY
Sun Medical, Inc.
Obstetrics & Gynecology · 126d
Cleared May 01, 1985
DOW CORNING WRIGHT TITANIUM WRIST JOINT GROMMET
K850255
Dow Corning Corp. Healthcare...
Orthopedic · 99d
Cleared May 01, 1985
KINETIC 8080 HAND & WRIST CONTIN. PASSIVE MACHINE
K850332 · BXB
Richards Medical Co., Inc.
Physical Medicine · 93d
Cleared May 01, 1985
SYNECTICS PH SYS COMPRISING DIGITRAPPER MARK II, E
K850361 · FFT
Synectics-Dantec
Gastroenterology & Urology · 91d
Cleared May 01, 1985
HI-LO TILT TABLE 625
K850377 · INQ
Tri W-G, Inc.
Physical Medicine · 91d
Cleared May 01, 1985
KIRSCHNER ORTHOPEDIC WIRE, EYELET CERCLAGE WIRES
K850631 · JDQ
Kirschner Medical Corp.
Orthopedic · 71d
Cleared May 01, 1985
ZIMMER THREADED ACETABULAR CUP
K850766 · KWA
Zimmer, Inc.
Orthopedic · 65d
Cleared May 01, 1985
DRESSING CHANGE KIT
K850887 · FOZ
Creative Care Systems, Inc.
General Hospital · 58d
Cleared May 01, 1985
GENERAL DIAGNOSTICS TICARCILLIN 75MCG SUSCEPT-DISK
K850957 · JTN
Warner-Lambert Co.
Microbiology · 54d