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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
141169–141192 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 12, 1987
MODEL NS-3CC NEURO-STIM PERIPHERAL NERVE STIMULAT
K864829 · BXN
Professional Instruments Co.
Anesthesiology · 34d
Cleared Jan 12, 1987
TEFLON-COATED HYPODERMIC NEEDLES/REGIONAL BLOCK
K864830 · BXN
Professional Instruments Co.
Anesthesiology · 34d
Cleared Jan 12, 1987
DALE VENIPUNCTURE TOURNIQUET, PRODUCT NO. 1335
K864897 · GAX
Dale Medical Products, Inc.
General & Plastic Surgery · 28d
Cleared Jan 12, 1987
SCANLAN (TM) VEIN/GRAFT HOLDER
K864919 · KPK
Scanlan Intl., Inc.
Cardiovascular · 27d
Cleared Jan 12, 1987
SCANLAN (TM) INSTRUMENT TRAY
K864920 · FSM
Scanlan Intl., Inc.
General & Plastic Surgery · 27d
Cleared Jan 12, 1987
BLOOD LANCET
K865016 · FMK
Falcon Medical Industries, Inc.
General & Plastic Surgery · 20d
Cleared Jan 12, 1987
SURGICAL GARMENTS
K865022 · FXO
Ulti-Med Intl., Inc.
General Hospital · 20d
Cleared Jan 12, 1987
COVER, SHOE OPERATING ROOM
K865023 · FXP
Ulti-Med Intl., Inc.
General Hospital · 20d
Cleared Jan 12, 1987
ANKLE HOLDER W/ANKLE SUPPORT KIT FOR LEG HOLDER
K865024 · FWZ
American Container Technology, Inc.
General & Plastic Surgery · 20d
Cleared Jan 12, 1987
BREAST PROSTHESIS (NON & INFLATABLE) SKIN EXPANDER
K865033 · LCJ
Cox-Uphuff Intl.
General & Plastic Surgery · 20d
Cleared Jan 12, 1987
TISSUE-EQUIVALENT BREAST SIMULATOR
K865100 · IXF
Computerized Imaging Reference...
Radiology · 13d
Cleared Jan 12, 1987
ADDITIONAL MODEL TO CANON UNIVERSAL STAND
K870048 · KPX
Canon USA, Inc.
Radiology · 6d
Cleared Jan 09, 1987
TRU-LEVEL CONTROL IMMUNOASSAY CONTROLS
K861202 · JJY
Nms Pharmaceuticals, Inc.
Chemistry · 284d
Cleared Jan 09, 1987
MODEL 10-C W/LP-10A/U & OB-10A/U FOR ORAL/ENT USE
K862865 · EWG
Directed Energy, Inc.
Ear, Nose, Throat · 164d
Cleared Jan 09, 1987
MODEL 10-C W/LP-10A/U & OS-10A/U FOR ORAL/ENT USE
K862866 · EWG
Directed Energy, Inc.
Ear, Nose, Throat · 164d
Cleared Jan 09, 1987
SONOLAYER-L, SAL-77B
K863947 · IYO
Toshiba Medical Systems
Radiology · 91d
Cleared Jan 09, 1987
VIS-CUBE PREGNANCY HOME TEST,CAT. # JPL-042
K863999 · LCX
Leeco Diagnostics, Inc.
Chemistry · 87d
Cleared Jan 09, 1987
SEP-PAK CARTRIDGES (LIQUID CHROMATOGRAPHY)
K864267 · DPM
Millipore Corp.
Chemistry · 72d
Cleared Jan 09, 1987
UNIMAX ITE & ULTRAMAX-CCR CUSTOM CANAL INSTRUMENTS
K864277 · ESD
Unimax Hearing Instruments
Ear, Nose, Throat · 71d
Cleared Jan 09, 1987
TERUMO OVATION SPECTROPHOTOMETER
K864285 · JJQ
Terumo Medical Corp.
Chemistry · 71d
Cleared Jan 09, 1987
IC MICROASSAY
K864312 · DAK
Diamedix Corp.
Immunology · 67d
Cleared Jan 09, 1987
CYTOLOGY BRUSHES
K864323 · HHT
Medical Packaging Corp.
Obstetrics & Gynecology · 67d
Cleared Jan 09, 1987
PACHYMETER SYSTEM V
K864336 · IYO
CooperVision, Inc.
Radiology · 66d
Cleared Jan 09, 1987
CLEARBLUE PREGNANCY TESTING KIT (MODIFICATION)
K864373 · LCX
Unipath , Ltd.
Chemistry · 65d