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
79465–79488 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Mar 02, 2001
HOMMED SENTRY III PATIENT MONITOR SYSTEM
K004044 · DQA
Hommed, LLC
Anesthesiology · 63d
Cleared Mar 02, 2001
ARROW REDIGUARD, 9FR. 50CC, INTRA-AORTIC BALLOON VATHETER, IAB-R950-U
K010330 · DSP
Arrow Intl., Inc.
Cardiovascular · 28d
Cleared Mar 02, 2001
M2376A DEVICELINK SYSTEM
K010453 · MWI
Agilent Technologies, Inc.
Cardiovascular · 15d
Cleared Mar 01, 2001
PROFOX SOFTWARE, MODEL 920M-41
K001708 · DQA
Respironics Georgia, Inc.
Anesthesiology · 269d
Cleared Mar 01, 2001
LASER 4SPSC340
K003059 · INI
Pride Mobility Products Corp.
Physical Medicine · 150d
Cleared Mar 01, 2001
ACCUCLOT CONTROL I, MODEL A4089
K003328 · GIZ
Sigma Diagnostics, Inc.
Hematology · 128d
Cleared Mar 01, 2001
SIGMA DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A5217
K003329 · GGC
Sigma Diagnostics, Inc.
Hematology · 128d
Cleared Mar 01, 2001
ASTRONOMER+WITH SLD
K003362 · DQK
Boston Scientific Corp
Cardiovascular · 125d
Cleared Mar 01, 2001
ELECSYS TESTOSTERONE CALSET II
K003411 · JIT
Roche Diagnostics Corp.
Chemistry · 119d