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
73825–73848 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 13, 2002
SYNTEX POWDER-FREE NITRILE EXAMINATION GLOVE, PURPLE COLOR
K022784 · LZA
Syntex Healthcare Products Co., Ltd.
General Hospital · 83d
Cleared Nov 13, 2002
SYNTHES ANTERIOR TENSION BAND (ATB) SYSTEM
K022791 · KWQ
Synthes (Usa)
Orthopedic · 83d
Cleared Nov 13, 2002
UNIVERSAL SYSTEM, MODEL QV-800
K023008 · KPR
Quantum Medical Imaging, LLC
Radiology · 65d
Cleared Nov 13, 2002
JIA CHEN ACUPUNCTURE NEEDLE, FOR SINGLE USE
K023054 · MQX
Mandala Health Care, LLC
General Hospital · 61d
Cleared Nov 13, 2002
MICRO-TOUCH NEXT STEP POWDER FREE MEDICAL EXAMINATION GLOVES WITH ALOE AND...
K023153 · LYY
Ansell Healthcare Products, Inc.
General Hospital · 51d
Cleared Nov 13, 2002
ORS-3000LD
K023282 · LHC
O.R. Solutions, Inc.
General Hospital · 43d
Cleared Nov 13, 2002
1075LD HUSH-SLUSH
K023283 · LHC
O.R. Solutions, Inc.
General Hospital · 43d
Cleared Nov 13, 2002
QUANTIX/ND DEVICE
K023431 · DPW
Cardiosonix, Ltd.
Cardiovascular · 29d
Cleared Nov 13, 2002
VARELISA CARDIOLIPIN ANTIBODIES SCREEN, MODELS 15848 AND 15896
K023433 · MID
Pharmacia Diagnostics GmbH & Co. KG
Immunology · 29d
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