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
99793–99816 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 06, 1995
UTK-DTE AUTILARY SHIELD
K954146 · KPY
Mallinckrodt Medical
Radiology · 92d
Cleared Dec 06, 1995
FACEPLATE (HEARING AID KIT)
K954236 · ESD
Truetone Hearing Systems, Inc.
Ear, Nose, Throat · 86d
Cleared Dec 06, 1995
BRAY RONGEUR
K954699 · HAE
Johnson & Johnson Professionals, Inc.
Neurology · 55d
Cleared Dec 06, 1995
TREBAY IRRIGATED CUTTER BLADE (MODIFICATION)
K954912 · EQJ
Trebay Medical Corp.
Ear, Nose, Throat · 44d
Cleared Dec 06, 1995
BELTONE ULTIMA 80 OTOSONIC POWER PAS
K954936 · ESD
Beltone Electronics Corp.
Ear, Nose, Throat · 40d
Cleared Dec 06, 1995
CAP-AID
K954959 · FHA
Nebl, Inc.
Gastroenterology & Urology · 40d
Cleared Dec 06, 1995
UROTRACT I
K955019 · KQS
Dornier Medtech America, Inc.
Radiology · 34d
Cleared Dec 06, 1995
OSOM HCG COMBO TEST
K955141 · JJX
Wyntek Diagnostics, Inc.
Chemistry · 23d
Cleared Dec 06, 1995
KUO & YANG SUNGLASSES
K955290 · HQY
Kuo & Yang Industrial Co., Ltd.
Ophthalmic · 19d
Cleared Dec 05, 1995
LIFE SOUND SENSOR AMPLIFIER-LISA
K953833 · DQD
Flowscan, Inc.
Cardiovascular · 112d
Cleared Dec 05, 1995
PTW-MP3 & PTW-MP3S AUTOMATIC WATER PHANTOM
K954165 · IYE
Ptw-New York Corp.
Radiology · 91d
Cleared Dec 05, 1995
CRISPICS
K954211 · LLZ
Merlin Engineering Works, Inc.
Radiology · 89d
Cleared Dec 05, 1995
ACCESS CORTISOL ASSAY (MODIFICATION)
K954733 · CGR
Bio-Rad Laboratories, Inc.
Chemistry · 64d
Cleared Dec 04, 1995
WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC LIGHT
K945876 · EQH
Wells Johnson Co.
Ear, Nose, Throat · 368d
Cleared Dec 04, 1995
VARAPULSE-2
K952680 · IPF
Staodyne, Inc.
Physical Medicine · 175d
Cleared Dec 04, 1995
CMS ACCUPROBE 550/530
K953637 · GEH
Cryomedical Sciences, Inc.
General & Plastic Surgery · 124d
Cleared Dec 04, 1995
DISCETOME TISSUE ASPIRATOR
K953998 · HRX
T. Korossurgical Instruments Corp.
Orthopedic · 102d
Cleared Dec 04, 1995
MSV-2000 VIDEO IMAGING SYSTEM
K954160 · GCJ
Applitec, Ltd.
General & Plastic Surgery · 90d
Cleared Dec 04, 1995
RE-BAG MULTI-USE POUCH, LARGE & SMALL
K954185 · KCT
Miltex, Inc.
General Hospital · 89d
Cleared Dec 04, 1995
REALITY LONG STEM HIP SYSTEM
K954219 · JDI
Kinamed, Inc.
Orthopedic · 87d
Cleared Dec 04, 1995
PROFORM POROUS BEADED FEMORAL STEM
K954466 · LPH
Stelkast Company
Orthopedic · 70d
Cleared Dec 04, 1995
SENDX 100 PH, BLOOD GAS & ELECTROLYTE ANALYSIS SYSTEM
K954482 · CHL
Cirrus Medical,Inc.
Chemistry · 68d
Cleared Dec 04, 1995
KARL STORZ HEMPFLING DILATION SET
K954981 · HRX
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 34d
Cleared Dec 04, 1995
RIGID NEUROVIEW ENDOSCOPE
K955037 · HRX
Neuro Navigational Corp.
Orthopedic · 31d