Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
80593–80616 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Mar 01, 2001
XTRAC EXCIMER LASER SYSTEM, MODEL AL7000
K003705 · GEX
Photo Medex, Inc.
General & Plastic Surgery · 90d
Cleared Mar 01, 2001
COOLTOUCH ND:YAG LASER SYSTEM, COOLTOUCH-II ND:YAG LASER SYSTEM, MODEL...
K003715 · GEX
Cooltouch Corp.
General & Plastic Surgery · 90d
Cleared Mar 01, 2001
INSTRUMENTS FOR LAPAROSCOPY 5 MM, 10 MM WITH COLOURED HANDLE, DETACHABLE...
K003717 · GEI
Tekno Medical Optik-Chirurgie GmbH & Co.
General & Plastic Surgery · 87d
Cleared Mar 01, 2001
240 PARUS ULTRASOUND IMAGING SYSTEMS, MODEL 240 PARUS
K003725 · IYO
Pie Medical
Radiology · 87d
Cleared Mar 01, 2001
TAKE 1
K003808 · ELW
Sybron Dental Specialties, Inc.
Dental · 83d
Cleared Mar 01, 2001
TI-REPLICA HIP STEM
K003875 · LPH
DePuy Orthopaedics, Inc.
Orthopedic · 76d
Cleared Mar 01, 2001
PALOMAR SPALIGHT PULSED LIGHT SYSTEM
K003886 · GEX
Palomar Medical Technologies, Inc.
General & Plastic Surgery · 73d