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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
18385–18408 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 05, 2020
UDE
K202292 · LLZ
Ebm Technologies, Inc.
Radiology · 54d
Cleared Oct 05, 2020
Affirm Contrast Biopsy
K202294 · IZH
Hologic, Inc.
Radiology · 53d
Cleared Oct 02, 2020
Arthrex SoftStitch
K190707 · GAT
Arthrex, Inc.
General & Plastic Surgery · 563d
Cleared Oct 02, 2020
Slow Wave DS8
K191320 · LQZ
Slow Wave, Inc.
Dental · 506d
Cleared Oct 02, 2020
SOZO Body Fluid Analyzer
K193410 · DSB
ImpediMed Limited
Gastroenterology & Urology · 298d
Cleared Oct 02, 2020
OssGuide
K200623 · NPL
Sk Bioland Co., Ltd.
Dental · 207d
Cleared Oct 02, 2020
BZF-29
K200682 · KLE
GC America, Inc.
Dental · 200d
Cleared Oct 02, 2020
Infrared Thermometer Model E127
K201161 · FLL
Bioland Technology, Ltd.
General Hospital · 155d
Cleared Oct 02, 2020
Encore System
K201238 · ORY
Siesta Medical, Inc.
Dental · 148d
Cleared Oct 02, 2020
X100 with Full Field Peripheral Blood Smear (PBS) Application
K201301 · JOY
Scopio Labs , Ltd.
Hematology · 140d
Cleared Oct 02, 2020
OsOpia Synthetic Bone Void Filler
K201546 · LYC
Revisios BV
Dental · 115d
Cleared Oct 02, 2020
HAL for Medical Use(Lower Limb type)
K201559 · PHL
Cyberdyne, Inc.
Neurology · 114d
Cleared Oct 02, 2020
Latex Powder Free Surgical Glove with Protein Labelling Claim of 50 Microgram...
K201748 · KGO
Hartalega Sdn Bhd
General Hospital · 98d
Cleared Oct 02, 2020
LiverMultiScan
K202170 · LNH
Perspectum, Ltd.
Radiology · 60d
Cleared Oct 02, 2020
Oculus-SA Lumbar Cage System
K202190 · OVD
Neurostructures
Orthopedic · 58d
Cleared Oct 02, 2020
Materialise PKA Guide System
K202207 · HSX
Materialise NV
Orthopedic · 57d
Cleared Oct 02, 2020
ZelanteDVT THrombectomy System, ZelanteDVT ClotHunter Helical Rotation Device
K202218 · QEW
Boston Scientific Corporation
Cardiovascular · 57d
Cleared Oct 02, 2020
Cleerly Labs v2.0
K202280 · LLZ
Cleerly, Inc.
Radiology · 52d
Cleared Oct 02, 2020
Quantum Workstation 12 Elite
K202557 · DRY
Spectrum Medical , Ltd.
Cardiovascular · 29d
Cleared Oct 01, 2020
MectaScope System
K200067 · HRX
Medacta International S.A.
Orthopedic · 262d
Cleared Oct 01, 2020
TELEGRAPH® EVOLUTION Humeral Nailing System
K200127 · HSB
FH Industrie
Orthopedic · 254d
Cleared Oct 01, 2020
SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+
K200544 · CEM
Diamond Diagnostics, Inc.
Chemistry · 212d
Cleared Oct 01, 2020
Infrared PT2L Digital No-Touch Thermometer
K200710 · FLL
Andon Health Co, Ltd.
General Hospital · 197d
Cleared Oct 01, 2020
ECG Cables and Leadwires
K201359 · DSA
Xinkang Medical Instrument Co. , Ltd.
Cardiovascular · 133d