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
108577–108600 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 28, 1994
GALLOR DENTAL MATERIAL & COPING INTRACAST TECHNOLO
K932243 · EJT
Precious Chemicals U.S.A., Inc.
Dental · 356d
Cleared Apr 28, 1994
HAND THERAPY ASSOST
K933418 · JFA
Bardon Ent., Inc.
Physical Medicine · 289d
Cleared Apr 28, 1994
ALASTIK
K933501 · EJF
Unitek Corp.
Dental · 283d
Cleared Apr 28, 1994
BIP MULTI MODIFICATION
K934371 · KNW
Bip USA, Inc.
Gastroenterology & Urology · 233d
Cleared Apr 28, 1994
PS MEDICAL DELTA BURR HOLE VALVE
K934545 · JXG
Pudenz-Schulte Medical Research Corp.
Neurology · 218d
Cleared Apr 28, 1994
COBALT CHROME GEMINI
K934909 · LWJ
Depuy, Inc.
Orthopedic · 196d
Cleared Apr 28, 1994
STRYKER ARTHROSCOPIC MANUAL SURGICAL INSTRUMENTS
K935221 · HRX
Stryker Endoscopy
Orthopedic · 178d
Cleared Apr 28, 1994
VECTOR AMBULATORY DRUG DELIVERY SYSTEM
K935461 · FIH
Infusion Technology Intl.
Gastroenterology & Urology · 167d
Cleared Apr 28, 1994
PHASE I CURETTE
K935822 · HCY
Phase I Corp.
Obstetrics & Gynecology · 146d
Cleared Apr 28, 1994
DENTAURUM SPACE MAINTAINER
K935856 · DYT
Dentauraum, Inc.
Dental · 141d
Cleared Apr 28, 1994
SCPU X-RAY GENERATOR
K940227 · IZO
General Electric Co.
Radiology · 100d
Cleared Apr 28, 1994
IODOFLEX PASTE
K940414 · KMF
Oclassen Pharmaceuticals, Inc.
General & Plastic Surgery · 90d
Cleared Apr 28, 1994
PRETREATMENT SOLUTION
K940685 · ELW
Dentsply Intl.
Dental · 77d
Cleared Apr 28, 1994
BENNETT MAMMOGRAPHY POSITIONING CHAIR MODEL NO. M-PCH
K940701 · IZH
Bennett X-Ray Corp.
Radiology · 71d
Cleared Apr 28, 1994
AUROLITE CB80
K941068 · EJT
Argen Precious Metals, Inc.
Dental · 51d
Cleared Apr 28, 1994
AUROLITE MT1
K941069 · EJT
Argen Precious Metals, Inc.
Dental · 51d
Cleared Apr 28, 1994
AUROLITE CB+2
K941070 · EJT
Argen Precious Metals, Inc.
Dental · 51d
Cleared Apr 28, 1994
AUROLITE CB25
K941071 · EJT
Argen Precious Metals, Inc.
Dental · 51d
Cleared Apr 28, 1994
FLEXIBLE BIOPSY CUP FORCEPS
K941158 · EOQ
Surgical Technologies, Inc.
Ear, Nose, Throat · 48d
Cleared Apr 26, 1994
ERGOMED
K912529 · GEH
Kryoderm USA, Inc.
General & Plastic Surgery · 1054d
Cleared Apr 26, 1994
PACE 2 NEISSERIA GONORRHOEAE PROBE CONFIRM. ASSAY
K920301 · LSL
Gen-Probe, Inc.
Microbiology · 826d
Cleared Apr 26, 1994
FLOW=MED
K924322 · BZH
International Electronic Technology...
Anesthesiology · 607d
Cleared Apr 26, 1994
CARDIAC T ELISA TROPONIN-T
K924392 · MMI
Boehringer Mannheim Corp.
Chemistry · 603d
Cleared Apr 26, 1994
PANOJECT MINIFUSOR MODEL 100 AMBULATORY INFUSION
K930494 · FRN
Elan Medical Technologies, Ltd.
General Hospital · 449d