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
99889–99912 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 27, 1995
SHARPS DISPOSAL CONTAINERS
K953797 · MMK
Bemis Mfg. Co.
General Hospital · 108d
Cleared Nov 27, 1995
RUSCH SINGLE LUMEN BRONCHIAL TUVBE SET, STERILE, FOR LEFT & RIGHT SIDED...
K953963 · BTS
Rusch, Inc.
Anesthesiology · 97d
Cleared Nov 27, 1995
RADIFOCUS INTRODUCER II KIT
K954234 · DYB
Terumo Medical Corp.
Cardiovascular · 77d
Cleared Nov 27, 1995
ANTI-TPO
K954256 · JNL
Biomerica, Inc.
Immunology · 83d
Cleared Nov 27, 1995
CONMED TROGARD ELECTRONIC TROCAR SYSTEM
K954599 · GEA
Conmedcorp
General & Plastic Surgery · 55d
Cleared Nov 27, 1995
CEDIA DAU BENZODIAZEPINE ASSAY(MODIFICATION)
K954626 · JXM
Microgenics Corp.
Toxicology · 55d
Cleared Nov 27, 1995
MILL-ROSE RIGID SCOPE CLEANING BRUSHES
K954745 · FEB
Mill-Rose Laboratory
General Hospital · 42d
Cleared Nov 27, 1995
EXPANDACELL INJECTO-PAK NASAL PACK
K954845 · EMX
Shippert Medical Technologies Corp.
Ear, Nose, Throat · 35d
Cleared Nov 27, 1995
MODEL NOS. 7495 AND 501826 EXTENSIONS
K954886 · GZB
Medtronic Vascular
Neurology · 151d
Cleared Nov 27, 1995
CHARISMA SINGLE DOSE
K954929 · EBF
Heraeus Kulzer, Inc.
Dental · 33d
Cleared Nov 27, 1995
DYONICS DISPOSABLE ENDOSCOPIC SURGERY BLADES
K954989 · ERL
Smith & Nephew Dyonics, Inc.
Ear, Nose, Throat · 27d
Cleared Nov 24, 1995
SIGNA ADVANTAGE SP MAGNETIC RESONANCE SYSTEM
K942604 · LNH
GE Medical Systems
Radiology · 541d
Cleared Nov 24, 1995
LASERNET IMAGE MANAGER/PRINT SERVER
K952485 · LMA
Frantz Imaging, Inc.
Radiology · 178d
Cleared Nov 24, 1995
VERTEX EPIC MCD
K952684 · KPS
Adac Laboratories
Radiology · 165d
Cleared Nov 24, 1995
CORTICELLOUS BONE SCREW
K953198 · HWC
Hayes Medical, Inc.
Orthopedic · 141d
Cleared Nov 24, 1995
VOXELVIEW
K953259 · LLZ
Vital Images, Inc.
Radiology · 135d
Cleared Nov 24, 1995
KENDALL SAFETAP SPINAL ANESTHESIA TRAY
K953766 · CAZ
Kendall Healthcare Products Co....
Anesthesiology · 102d
Cleared Nov 24, 1995
PENTAX ULTRASOUND ENDOSCOPE MODEL FG-32UA (MODIFICATION)
K953876 · ODG
Pentax Precision Instrument Corp.
Radiology · 109d
Cleared Nov 24, 1995
GYREX PRIVILEGE
K954039 · LNH
Elscint, Inc.
Radiology · 88d
Cleared Nov 24, 1995
AQUASOFT (TETRAFILCON A) DAILY WEAR SOFT (HYDROPHILIC) CONTACT LENS
K954139 · LPL
CooperVision, Inc.
Ophthalmic · 84d
Cleared Nov 24, 1995
HUMPHREY FIELD ANALYZER (HFA II)
K954167 · HPT
Carl Zeiss, Inc.
Ophthalmic · 80d
Cleared Nov 24, 1995
SYNTHES CANNULATED ANGLE BLADE PLATE
K954289 · KTW
Synthes (Usa)
Orthopedic · 71d
Cleared Nov 24, 1995
MPH50, MPH65, AND MPH80
K954666 · IZO
GE Medical Systems
Radiology · 45d
Cleared Nov 24, 1995
CHOLESTECH LDX SYSTEM
K954778 · LBS
Cholestech Corp.
Chemistry · 66d