FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
70945–70968 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 12, 2003
S-MONOVETTE EDTA K2-GEL
K031359 · PJE
Sarstedt, Inc.
Chemistry · 135d
Cleared Sep 12, 2003
CD HORIZON SPINAL SYSTEM
K032033 · NKB
Medtronic Sofamor Danek
Orthopedic · 73d
Cleared Sep 12, 2003
SAFETY-MULTIFLY
K032150 · FPA
Sarstedt, Inc.
General Hospital · 60d
Cleared Sep 12, 2003
DURACON TOTAL KNEE SYSTEM
K032163 · MBH
Howmedica Osteonics Corp.
Orthopedic · 59d
Cleared Sep 12, 2003
QUANTUM WARP 10 LIGHT DELIVERY SYSTEM
K032229 · ILY
Quantum Devices, Inc.
Physical Medicine · 53d
Cleared Sep 12, 2003
INDUCTION AND SAMPLING MANIFOLD (OR STOPCOCK)
K032393 · FMG
Elcam Medical Acal
General Hospital · 39d
Cleared Sep 12, 2003
3.0T 8-CHANNEL CERVICAL-THORACIC-LUMBAR (CTL) ARRAY COIL
K032538 · MOS
Usa Instruments, Inc.
Radiology · 25d
Cleared Sep 12, 2003
POLESTAR N-20
K032541 · LNH
Odin Medical Technologies , Ltd.
Radiology · 25d
Cleared Sep 12, 2003
ACCU-CHEK ADVANTAGE SYSTEM
K032552 · NBW
Roche Diagnostics Corp.
Chemistry · 24d
Cleared Sep 12, 2003
MODIFICATION TO FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM)
K032588 · HSB
Disco-O-Tech Medical Technologies, Ltd.
Orthopedic · 21d
Cleared Sep 12, 2003
3.0T 8 CHANNEL NEUROVASCULAR (NV) ARRAY COIL
K032618 · MOS
Usa Instruments, Inc.
Radiology · 17d
Cleared Sep 12, 2003
RS-4I MUSCLE STIMULATOR FAMILY
K032652 · IPF
Rs Medical
Physical Medicine · 15d
Cleared Sep 12, 2003
E275
K032653 · GZJ
Micro Current Technology, Inc.
Neurology · 15d
Cleared Sep 12, 2003
VORTEX MP
K032754 · LJT
Horizon Medical Products, Inc.
General Hospital · 7d
Cleared Sep 11, 2003
LATEX ULTRASONIC PROBE COVER
K022156 · ITX
Pleasure Latex Products Sdn. Bhd.
Radiology · 436d
Cleared Sep 11, 2003
B.T.I. BIOTECHNOLOGY INSTITUTE, S.L. DENTAL IMPLANT SYSTEM
K022258 · DZE
B.T.I. Biotechnology Institute, Sl.
Dental · 426d
Cleared Sep 11, 2003
COMPOSITE RESTORATION MATERIAL
K031721 · EBF
Milton Hodosh, M.D.
Dental · 100d
Cleared Sep 11, 2003
PANTOS, MODELS: PANTOS 16, AND PANTOS DG
K031801 · MUH
Blue X Imaging Srl
Radiology · 92d
Cleared Sep 11, 2003
QUICKVUE INFLUENZA A+B TEST
K031899 · PSZ
Quidel Corp.
Microbiology · 99d
Cleared Sep 11, 2003
TRANSDISCAL SYSTEM (TRANSDISCAL PROBE), MODEL TDP-17-150-6
K031951 · GEI
Baylis Medical Co., Inc.
General & Plastic Surgery · 79d
Cleared Sep 11, 2003
SPINAL CONCEPTS INC. NEX-LINK SPINAL FIXATION SYSTEM
K031985 · MNI
Spinal Concepts, Inc.
Orthopedic · 76d
Cleared Sep 11, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM CEFOTAXIME 0.5-64 UG/ML
K032153 · LON
Bd Diagnostic Systems
Microbiology · 59d
Cleared Sep 11, 2003
DURACON TOTAL KNEE SYSTEM WITH PERI-APATITE COATING
K032418 · MBH
Howmedica Osteonics Corp.
Orthopedic · 37d
Cleared Sep 11, 2003
RESUME II LEAD KIT FOR SPINAL CORD STIMULATION (SCS) AND PERIPHERAL NERVE...
K032561 · GZB
Medtronic Vascular
Neurology · 22d