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
36937–36960 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 29, 2014
CAMERA ENABLED PROBE
K141119 · HRX
Trice Medical, Inc.
Orthopedic · 90d
Cleared Jul 29, 2014
ZIMMER ZFX TITANIUM ABUTMENT FOR STRAUMANN BONE LEVEL IMPLANT SYSTEM
K141120 · NHA
Zimmer Dental, Inc.
Dental · 90d
Cleared Jul 29, 2014
VITALCONNECT PLATFORM (CONSISTING OF VITALCONNECT SENSOR, RELAY SOFTWARE...
K141167 · DRG
Vitalconnect, Inc.
Cardiovascular · 84d
Cleared Jul 29, 2014
CAREFINE PEN NEEDLE FAMILY INCLUDING QUINTAPOINT AND SUPERPOINT
K141749 · FMI
Facet Technologies, LLC
General Hospital · 29d
Cleared Jul 29, 2014
ALTEON 6.5MM BONE SCREWS
K141797 · LPH
Exactech, Inc.
Orthopedic · 27d
Cleared Jul 28, 2014
GENERICA MEDICAL ENTERNAL DELIVERY
K133077 · KNT
Generica Medical International, Inc.
Gastroenterology & Urology · 301d
Cleared Jul 28, 2014
OSTEOFAB PATIENT SPECIFIC FACIAL DEVICE
K133809 · KKY
Oxford Performance Materials
General & Plastic Surgery · 224d
Cleared Jul 28, 2014
HUMELOCK II CEMENTED SHOULDER SYSTEM
K140071 · KWT
Fx Solutions
Orthopedic · 196d
Cleared Jul 28, 2014
STOPSBLEEDING TOPICAL HEMOSTAT POWDER AND FOAM
K140313 · QSY
Coag Medical, LLC
General & Plastic Surgery · 168d
Cleared Jul 28, 2014
MR SYRINGE DUAL PACK
K140469 · DXT
Coeur, Inc.
Cardiovascular · 153d
Cleared Jul 28, 2014
COROENT XL-F SYSTEM
K140479 · OVD
Nu Vasive, Incorporated
Orthopedic · 152d
Cleared Jul 28, 2014
COROENT SMALL INTERBODY SYSTEM
K140921 · ODP
Nu Vasive, Incorporated
Orthopedic · 109d
Cleared Jul 28, 2014
KIMGUARD ONE-STEP STERILIZATION WRAP
K141071 · FRG
Kimberly-Clark Health Care
General Hospital · 94d
Cleared Jul 28, 2014
AQUARIUS EXTENSION FEEDING SET
K141631 · KNT
Degania Silicone , Ltd.
Gastroenterology & Urology · 40d
Cleared Jul 28, 2014
ACE CALIBRATOR
K141728 · JIT
SENTINEL CH. SpA
Chemistry · 32d
Cleared Jul 25, 2014
BNA ANALYSIS SYSTEM
K121119 · OLU
Eiminda , Ltd.
Neurology · 834d
Cleared Jul 25, 2014
HIVOX SELF ADHESIVE ELECTRODE GEL PADS
K131720 · GXY
Hivox Biotek, Inc.
Neurology · 408d
Cleared Jul 25, 2014
STEALTHSTATION S7 / I7 / FUSION NAVIGATION SYSTEMS, AXIEM NAVIGATION SYSTEM
K133444 · HAW
Medtronic Navigation, Inc.
Neurology · 255d
Cleared Jul 25, 2014
CELLVIZIO 100 SERIES SYSTEM WITH CONFOCAL MINIPROBES (TM)
K133466 · OWN
Mauna Kea Technologies
General & Plastic Surgery · 255d
Cleared Jul 25, 2014
CDI BLOOD PARAMETER MONITORING SYSTEM 500
K133658 · DRY
Terumo Cardiovascular Systems Corp.
Cardiovascular · 240d
Cleared Jul 25, 2014
BELTER BLOOD PRESSURE METER
K134029 · DXN
Shenzhen Belter Health Measurement...
Cardiovascular · 206d
Cleared Jul 25, 2014
3M STERI-DRAPE CHG ANTIMICROBIAL INCISE DRAPE
K140250 · KKX
3M Healthcare
General Hospital · 175d
Cleared Jul 25, 2014
V-PRO STERILIZATION TRAY/ STERILIZATION MAT
K140494 · KCT
STERIS Corporation
General Hospital · 148d
Cleared Jul 25, 2014
ENDOWRIST STAPLER 45 AND STAPLER 45 RELOADS
K140553 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 143d