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
79969–79992 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 07, 2001
GENERAL SURGICAL LAPAROSCOPES
K003803 · GCJ
Global Endoscopy, Inc.
General & Plastic Surgery · 89d
Cleared Mar 07, 2001
FLEXVIEW CLINICAL MONITORING SYSTEM
K003998 · MSX
Data Critical Corp.
Cardiovascular · 71d
Cleared Mar 07, 2001
SLT DIFFUSER FIBER
K010041 · GEX
Surgical Laser Technologies, Inc.
General & Plastic Surgery · 61d
Cleared Mar 07, 2001
SCIMEDX PHASE II MPO IGG ANTIBODY EIA
K010289 · MOB
Scimedx Corp.
Immunology · 35d
Cleared Mar 07, 2001
ARTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 200
K010338 · DWJ
Medivance, Inc.
Cardiovascular · 30d
Cleared Mar 07, 2001
ENDOCARE PERCUTANEOUS ACCESS SET
K010339 · KOD
Endocare, Inc.
Gastroenterology & Urology · 30d
Cleared Mar 07, 2001
ACCU-CHEK COMFORT CURVE TEST STRIP
K010362 · LFR
Roche Diagnostics Corp.
Chemistry · 29d
Cleared Mar 06, 2001
SHAVER ABLATOR
K002088 · HRX
Linvatec Corp.
Orthopedic · 238d
Cleared Mar 06, 2001
FETAL ASSIST
K002548 · HGM
Huntleigh Diagnostics , Ltd.
Obstetrics & Gynecology · 201d
Cleared Mar 06, 2001
SWABSITE SWABBABLE VALVE, MODEL 245000
K002689 · FPA
Quest Medical, Inc.
General Hospital · 189d
Cleared Mar 06, 2001
LYRA G SERIES SURGICAL LASER SYSTEM (SL SERIES Q-SWITCHED ND:YAG CONFIGURATION)
K003765 · GEX
Laserscope
General & Plastic Surgery · 90d
Cleared Mar 06, 2001
CARIS SITE MARKER
K003777 · FZP
Artemis Medical, Inc.
General & Plastic Surgery · 89d
Cleared Mar 06, 2001
INJEX 50 SYSTEM
K003864 · KZE
Equidyne Systems, Inc.
General Hospital · 83d
Cleared Mar 06, 2001
SUSCEPTIBILITY TEST PANEL
K004045 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 67d
Cleared Mar 06, 2001
D.SIGN 30
K010381 · EJH
Ivoclar North America, Inc.
Dental · 26d
Cleared Mar 06, 2001
MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS...
K010419 · DQA
Masimo Corp.
Anesthesiology · 22d
Cleared Mar 05, 2001
GRAMS POLYESTER NONABSORBABLE SUTURE
K003590 · GAT
Gramsmed, LLC
General & Plastic Surgery · 104d
Cleared Mar 05, 2001
MENTOR SELF-CATH PLUS
K003784 · EZL
Mentor Corp.
Gastroenterology & Urology · 88d
Cleared Mar 05, 2001
MULTI CARE THERAPEUTIC VIBRATOR
K010096 · KXQ
Multicept A/S
Obstetrics & Gynecology · 53d
Cleared Mar 05, 2001
VIGIL SEROLOGY CONTROL LEVEL C
K010358 · JJY
Beckman Coulter, Inc.
Immunology · 27d
Cleared Mar 02, 2001
TRANSANAL ENDOSCOPIC MICROSURGERY (TEM) COMBINATION SYSTEM AND INSTRUMENT...
K000180 · HIF
Richard Wolf Medical Instruments Corp.
Obstetrics & Gynecology · 407d
Cleared Mar 02, 2001
SNAP MODEL 6
K002095 · MNR
Snap Laboratories, LLC
Anesthesiology · 234d
Cleared Mar 02, 2001
SAN UP S.A. NEBULIZER COMPRESSOR, WITH DISPOSABLE NEBULIZER, MODEL 3050
K002468 · BTI
San UP S.A.
Anesthesiology · 203d
Cleared Mar 02, 2001
INTUITIVE SURGICAL DA VINCI ENDOSCOPIC CONTROL SYSTEM
K002489 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 204d