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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
105793–105816 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 10, 1994
MEDI-TRACE NEONATAL ECG ELECTRODE WITH PREATTACHED LEADWIRE
K945214 · DRX
Graphic Controls Corp.
Cardiovascular · 16d
Cleared Nov 09, 1994
AQUADYNE
K930820 · ILJ
Aquatherapy Systems, Inc.
Physical Medicine · 630d
Cleared Nov 09, 1994
THERA-FIT
K930821 · ILJ
Aquatherapy Systems, Inc.
Physical Medicine · 630d
Cleared Nov 09, 1994
EAST WEST INSTRUMENTS
K941193 · MDM
East West Instruments, Inc.
General & Plastic Surgery · 243d
Cleared Nov 09, 1994
ENVISION ARTHROSCOPY SYSTEM
K942081 · HRX
Envision Surgical System, Inc.
Orthopedic · 194d
Cleared Nov 09, 1994
SONOCA III
K942095 · LFL
Holl Meditronics, Inc.
General & Plastic Surgery · 203d
Cleared Nov 09, 1994
ORTHOPAEDIC WIRES
K942603 · LRN
Acu Med, Inc.
Orthopedic · 161d
Cleared Nov 09, 1994
VILLALTA RETRACTOR
K943875 · GAD
Hct, Inc.
General & Plastic Surgery · 93d
Cleared Nov 09, 1994
ECLIPSE 3200
K944153 · GEX
Cardiogenes
General & Plastic Surgery · 90d
Cleared Nov 09, 1994
IMPLANTECH MEDICAL GRADE SILICONE SHEETING
K944408 · MIB
King & Spalding
General & Plastic Surgery · 62d
Cleared Nov 09, 1994
ACM PTFE SURGICAL MESH
K944413 · FTL
American Custom Medical, Inc.
General & Plastic Surgery · 62d
Cleared Nov 09, 1994
MODEL 230-SAS LASER DELIVERY PROBE
K944630 · GEX
Mnlase, Inc.
General & Plastic Surgery · 50d
Cleared Nov 09, 1994
NEUTRALECT ADULT STANDARD, RETURN (REM), PAEDIATRIC STANDARD, RETURN (REM)
K944817 · GEI
Msb , Ltd.
General & Plastic Surgery · 41d
Cleared Nov 09, 1994
AESCULAP THORACOSCOPIC INSTRUMENTS
K944955 · KNS
Aesculap, Inc.
Gastroenterology & Urology · 33d
Cleared Nov 09, 1994
KARL STORZ SUCTION/IRRIGATION TUBES. CANNULAE, SHEATHS
K945059 · GCJ
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 26d
Cleared Nov 09, 1994
KARL STORZ RETRACTORS, PROBES, DISSECTORS, HOOKD
K945101 · GCJ
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 22d
Cleared Nov 09, 1994
MODIFIED BIOPSY NEEDLE
K945133 · FCG
Biopsys Medical, Inc.
Gastroenterology & Urology · 20d
Cleared Nov 09, 1994
E3590, SMOKE EVACUATION ATTCHMENT FOR ELECTROSURGICAL PENCILS
K945260 · GEI
Valleylab, Inc.
General & Plastic Surgery · 12d
Cleared Nov 09, 1994
DISPOSABLE & REUSABLE CHUCK HANDLE
K945299 · GEI
Boston Surgical Products, Inc.
General & Plastic Surgery · 9d
Cleared Nov 08, 1994
FOUNDATION POSTERIOR STABILIZED KNEE
K933539 · JWH
Encore Orthopedics, Inc.
Orthopedic · 475d
Cleared Nov 08, 1994
MANDELKORN SUTURE LYSIS LENS
K933976 · HJK
Ocular Instruments, Inc.
Ophthalmic · 452d
Cleared Nov 08, 1994
EMS-250
K934556 · IPF
Electronic Medical Sciences, Inc.
Physical Medicine · 474d
Cleared Nov 08, 1994
CODMAN ANTERIOR CERVICAL SPINE PLATE SYSTEM
K934756 · KWQ
Codman & Shurtleff, Inc.
Orthopedic · 399d
Cleared Nov 08, 1994
PRINCE
K935586 · DXH
Instromedix, Inc.
Cardiovascular · 363d