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
102241–102264 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 21, 1995
VERSATELL
K941959 · HCC
Progressive Concepts, Inc.
Neurology · 425d
Cleared Jun 21, 1995
BRAUN MANIFOLD
K942391 · DTL
B.Braun Medical, Inc.
Cardiovascular · 398d
Cleared Jun 21, 1995
MSI PROCEDURE KIT
K944226 · DOX
Msi, Inc.
Toxicology · 295d
Cleared Jun 21, 1995
COWBOY X
K944567 · JOW
Kinetic Concepts, Inc.
Cardiovascular · 275d
Cleared Jun 21, 1995
GRAHAM-FIELD ULTRASOUND SCANNING GEL
K944597 · IYO
Chester Labs, Inc.
Radiology · 275d
Cleared Jun 21, 1995
EVOLUTION(TM) MICROCATHETER
K945666 · KRA
Boston Scientific Corp
Cardiovascular · 216d
Cleared Jun 21, 1995
DUAL PURPOSE CATHETER
K945994 · BSY
Universal Medical Products, Inc.
Anesthesiology · 211d
Cleared Jun 21, 1995
LEMAITRE VALVULOTOME II
K946352 · MGZ
Vascutech, Inc.
Cardiovascular · 173d
Cleared Jun 21, 1995
MICROFLOW IRRIGATION SYSTEM
K950078 · KMA
Jedmed Instrument Co.
Ear, Nose, Throat · 162d
Cleared Jun 21, 1995
CYBEX 770
K950095 · IKK
Cybex
Physical Medicine · 162d
Cleared Jun 21, 1995
THE IMED ORION INFUSION PUMP AND ADMINISTRATION SETS
K950419 · FRN
Imed Corp.
General Hospital · 141d
Cleared Jun 21, 1995
GENT-L-KARE TRACHEOSTOMY TRAYS
K950851 · LRQ
Premium Plastics, Inc.
General & Plastic Surgery · 117d
Cleared Jun 21, 1995
BIODERM MEDICAL HYDROGEL ISLAND DRESSING
K951166 · NAE
Bioderm, Inc.
General & Plastic Surgery · 99d
Cleared Jun 21, 1995
EBI SMALL EXTERNAL FIXATOR (S/E/F/)
K951357 · KTT
Electro-Biology, Inc.
Orthopedic · 89d
Cleared Jun 21, 1995
ENDOPATH AND PROXIMATE LINEAR CUTTERS AND STAPLERS
K951546 · GCJ
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 82d
Cleared Jun 21, 1995
S-ROM ZTP UHMWPE ACETABULAR CUP
K951726 · JDI
Joint Medical Products Corp.
Orthopedic · 68d
Cleared Jun 21, 1995
FORTE CB
K951746 · IMG
Chattanooga Group, Inc.
Physical Medicine · 97d
Cleared Jun 21, 1995
LEONARD ARM - SUPPORT ARM - ENDOSCOPIC ACCESSORY
K951854 · FQO
Leonard Medical, Inc.
General & Plastic Surgery · 61d
Cleared Jun 21, 1995
PISTON SYRINGE
K951871 · FMF
Baxa Corp.
General Hospital · 61d
Cleared Jun 21, 1995
RYNEL MEDICAL FOAM
K951909 · KMF
Rynel, Ltd. Inc.
General & Plastic Surgery · 58d
Cleared Jun 21, 1995
GAUZE, NONABSORABABLE, X-RAY DETECTABLE (INTERNAL SPONGE)
K951911 · GDY
Commercial Resources New Mexico, Ltd.
General & Plastic Surgery · 58d
Cleared Jun 21, 1995
LISTENAIDER II
K952057 · LZI
National Hearing Aid Dist., Inc.
Ear, Nose, Throat · 50d
Cleared Jun 21, 1995
FOCUS BALLOON DILATATION CATHETER
K952064 · LIT
Cardiovascular Dynamics, Inc.
Cardiovascular · 50d
Cleared Jun 21, 1995
AUROLITE 80
K952403 · EJT
Argen Precious Metals, Inc.
Dental · 30d