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
73321–73344 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 13, 2002
MODIFICATION TO MONARCH SPINE SYSTEM
K023438 · MNH
Depuyacromed
Orthopedic · 29d
Cleared Nov 13, 2002
DEPUY SUMMIT FX CEMENTED HIP PROSTHESIS
K023453 · JDI
DePuy Orthopaedics, Inc.
Orthopedic · 29d
Cleared Nov 13, 2002
EVEREST BIPOLAR CUTTING FORCEPS AND GYRUS BIPOLAR CUTTING FORCEPS
K023492 · GEI
Gyrus Medical, Inc.
General & Plastic Surgery · 26d
Cleared Nov 13, 2002
PK ZIP WING CUTTING DISSECTOR
K023493 · GEI
Gyrus Medical, Inc.
General & Plastic Surgery · 26d
Cleared Nov 13, 2002
MODIFICATION TO BLACKSTONE SPINAL FIXATION SYSTEM
K023498 · KWP
Blackstone Medical, Inc.
Orthopedic · 26d
Cleared Nov 13, 2002
MODIFICATION TO ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER
K023504 · LIT
Cook, Inc.
Cardiovascular · 26d
Cleared Nov 13, 2002
MODIFICATION TO CLASSIC GREAT TOE IMPLANT
K023562 · KWH
Nexa Orthopedics, Inc.
Orthopedic · 21d
Cleared Nov 13, 2002
SPI EASY DENTAL IMPLANT ABUTMENT
K023645 · NHA
Thommen Medical AG
Dental · 14d
Cleared Nov 13, 2002
EXATECH ACUMATCH INTEGRATED HIP SYSTEM C-SERIES CEMENTED FEMORAL STEM
K023646 · JDI
Exactech, Inc.
Orthopedic · 14d
Cleared Nov 12, 2002
CA 15-3 ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
K022178 · MOI
Bayer Diagnostics Corp.
Immunology · 132d
Cleared Nov 12, 2002
INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENT CONTROL SYSTEM & ENDOSCOPIC...
K022574 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 102d
Cleared Nov 12, 2002
KLARITY
K022708 · IYE
Larson Products, Inc.
Radiology · 90d
Cleared Nov 12, 2002
HAND DRILL, MODEL 11-9901-7
K022712 · HBG
Medical Design, LLC
Neurology · 90d
Cleared Nov 12, 2002
MIDAS TOUCH BLUE LATEX EXAMINATION GLOVES - POEDER FREE
K023159 · LYY
Industrial Clothings, Ltd.
General Hospital · 50d
Cleared Nov 12, 2002
SENSICARE -C SYNTHETIC POLYISOPRENE POWDER-FREE SURGICAL GLOVES
K023236 · KGO
Maxxim Medical
General Hospital · 46d
Cleared Nov 12, 2002
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM
K023301 · LON
Becton, Dickinson & CO
Microbiology · 40d
Cleared Nov 12, 2002
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-AMIKACIN-0.5-64 UG/ML
K023444 · LON
Becton, Dickinson & CO
Microbiology · 28d
Cleared Nov 12, 2002
ESSEX ENDOSCOPE, MODEL SXD-1000
K023627 · GCJ
Guidant Corp.
General & Plastic Surgery · 15d
Cleared Nov 12, 2002
ESSEX DISSECTION CANNULA, MODEL SXD-1100, ESSEX DISSECTION TIP, MODEL SXD-1200
K023629 · GCJ
Guidant Corporation, Cardiac Surgery
General & Plastic Surgery · 15d
Cleared Nov 08, 2002
BILITEC 2000, POLYGRAM '98 PH TESTING APPLICATION (INCL.BILE), OPTICAL FIBER...
K011471 · FFX
Medtronic Functional Diagnostics A/S
Gastroenterology & Urology · 543d
Cleared Nov 08, 2002
PHILIPS M5066A AND M5068A
K020715 · MKJ
Philips Medical Systems
Cardiovascular · 248d
Cleared Nov 08, 2002
EIKON AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-400M
K021239 · DXN
Eikon Healthcare Device Corp.
Cardiovascular · 204d
Cleared Nov 08, 2002
EIKON AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-200M/HD-200
K021240 · DXN
Eikon Healthcare Device Corp.
Cardiovascular · 204d
Cleared Nov 08, 2002
PNEUMOPERITONEUM INSUFFLATION NEEDLE
K021247 · HIF
Mectra Labs, Inc.
Obstetrics & Gynecology · 203d