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
135481–135504 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 03, 1988
SUREDROP EYEDROP GUIDE
K874569 · JYJ
Suredrop, Inc.
Ear, Nose, Throat · 180d
Cleared May 03, 1988
ILLUMINATING INFUSION CONTACT LENS FOR EYE SURGERY
K874591 · HPX
Vitreo Dynamics, Co.
Ophthalmic · 176d
Cleared May 03, 1988
OCU-1
K875030 · HMX
Rudolph Beaver, Inc.
Ophthalmic · 148d
Cleared May 03, 1988
ULTRASOUND DIATHERMY UNIT ULTRASOUND HEATER
K875381 · IMI
Ford Laboratories, Inc.
Physical Medicine · 148d
Cleared May 03, 1988
CYSTOTOMES/KNIFES
K880345 · HNY
Myocure, Inc.
Ophthalmic · 98d
Cleared May 03, 1988
CANNULAS
K880346 · HMX
Myocure, Inc.
Ophthalmic · 98d
Cleared May 03, 1988
ANESTHESIA/RETROBULBAR NEEDLES
K880347 · HMX
Myocure, Inc.
Ophthalmic · 98d
Cleared May 03, 1988
BLUE PLASTIC EYE SHIELD
K880490 · HOY
Eye Garter Company, Inc.
Ophthalmic · 89d
Cleared May 03, 1988
MEDSURG 7 FR. DUAL LUMEN CENTRAL VEIN CATH SYSTEM
K880771 · DQR
Medsurg Industries, Inc.
Cardiovascular · 67d
Cleared May 03, 1988
MODEL PC ARGON LASER
K880908 · GEX
Hgm, Inc.
General & Plastic Surgery · 61d
Cleared May 03, 1988
AUTOMATIC PERIMETER, AP-340
K881219 · HPT
Kowa Optimed, Inc.
Ophthalmic · 42d
Cleared May 03, 1988
PORGES URETERAL STENT
K881744 · FAD
Bivona Medical Technologies
Gastroenterology & Urology · 11d
Cleared May 02, 1988
INFANT CANNULA
K873012 · DQR
Gresco International, Inc.
Cardiovascular · 272d
Cleared May 02, 1988
ACUSON S228 AND S328 TRANSDUCERS FOR ABDOM. APPLI.
K874363 · IYO
Acuson Computed Sonography
Radiology · 192d
Cleared May 02, 1988
SL SERIES, SL 15, 18, 20 & 25
K874558 · IYE
Philips Medical Systems, Inc.
Radiology · 180d
Cleared May 02, 1988
10 AND 12 FRENCH VESSEL DILATORS
K874738 · DRE
Impra, Inc.
Cardiovascular · 166d
Cleared May 02, 1988
XENEX DENTAL ROULETTE
K880485 · EFW
G & A Industries, Inc.
Dental · 88d
Cleared May 02, 1988
MAMMOGRAPHIC X-RAY SYSTEM ATHENA
K880531 · IZH
Fischer Imaging Corp.
Radiology · 83d
Cleared May 02, 1988
DENTALVISION TV SYSTEM
K880542 · EKJ
Dentsply Intl.
Dental · 83d
Cleared May 02, 1988
MINOS AUTOMATIC CELL COUNTER
K880616 · GKZ
Abx, Inc.
Hematology · 76d
Cleared May 02, 1988
FIBEROPTIC CATHETER
K880661 · DQO
Optimed Technologies, Inc.
Cardiovascular · 75d
Cleared May 02, 1988
ENDOMED CV405
K880699 · IPF
Henley Intl.
Physical Medicine · 70d
Cleared May 02, 1988
7 FR. TRIPLE LUMEN CENTRAL VEIN CATHETERI. SYSTEM
K880776 · DQR
Medsurg Industries, Inc.
Cardiovascular · 66d
Cleared May 02, 1988
RESUBMITTED ERGOMETER EXERCISE BIKE MODEL FT1300
K880865 · BXB
Invacare Corp.
Physical Medicine · 62d