FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
126649–126672 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 03, 1990
LISS CRANIAL STIMULATOR MODEL SBL201-M
K894515 · QJQ
Medical Consultants Intl. , Ltd.
Neurology · 288d
Cleared May 03, 1990
DANTEC MENUET
K896575 · FAP
Dantec Medical, Inc.
Gastroenterology & Urology · 164d
Cleared May 03, 1990
HEARTSTART 3000
K896919 · MKJ
Laerdal Medical Corp.
Cardiovascular · 142d
Cleared May 03, 1990
MODEL N742 SUNGLASSES W/ACRYLIC NIGHT DRIVER LENS
K900520 · HQY
J & B Assoc.
Ophthalmic · 90d
Cleared May 03, 1990
MODEL N742 SUNGLASSES W/POLYCARBONATE BLUE BLOCKER
K900521 · HQY
J & B Assoc.
Ophthalmic · 90d
Cleared May 03, 1990
MODEL N741 SUNGLASSES W/ACRYLIC BLUE COMPUTER LENS
K900522 · HQY
J & B Assoc.
Ophthalmic · 90d
Cleared May 03, 1990
MODEL F3 FLIP UP SUNGLASSES W/POLORIZED COMPUTER
K900524 · HQY
J & B Assoc.
Ophthalmic · 90d
Cleared May 03, 1990
MODEL F 1 FLIP-UP SUNGLASSES W/POLORIZED LENS
K900526 · HQY
J & B Assoc.
Ophthalmic · 90d
Cleared May 03, 1990
MODEL S139029 SUNGLASSES W/MIRROR ACRYLIC LENSES
K900527 · HQY
J & B Assoc.
Ophthalmic · 90d
Cleared May 03, 1990
MODEL 8806 SD SUNGLASSES W/ACRYLIC LENSES
K900528 · HQY
J & B Assoc.
Ophthalmic · 90d
Cleared May 03, 1990
MODEL 9018 PC SUNGLASSES W/POLYCARBONATE LENSES
K900529 · HQY
J & B Assoc.
Ophthalmic · 90d
Cleared May 03, 1990
MODEL DLASE 300 ND:YAG LASER SYSTEM: INTRAORAL
K900539 · GEX
Sunrise Technologies, Inc.
General & Plastic Surgery · 87d
Cleared May 03, 1990
CHLAMYDIAZYME DIAGNOSTIC KIT
K900543 · LJC
Abbott Laboratories
Microbiology · 87d
Cleared May 03, 1990
RICHARD-ALLAN VESSEL LOOPS
K900566 · KDC
Richard-Allan Medical Ind., Inc.
General & Plastic Surgery · 85d
Cleared May 03, 1990
HERAEUS LASERSONICS CO2 WAVEGUIDE DELIVERY SYSTEM
K900751 · GEX
Heraeus Lasersonics, Inc.
General & Plastic Surgery · 69d
Cleared May 03, 1990
MEDICAM ARTHROSCOPE SYSTEMS
K900812 · HRX
Kirschner Medical Corp.
Orthopedic · 71d
Cleared May 03, 1990
KOPANS HOOKWIRE LESION LOCALIZATION NEEDLE
K900903 · GDF
Milex Products, Inc.
General & Plastic Surgery · 65d
Cleared May 03, 1990
MODIFIED UNIPOLAR IMPLANT. PACING LEADS W/IS-1
K900984 · DTB
Medtronic Vascular
Cardiovascular · 63d
Cleared May 03, 1990
HEXASCAN HANDPIECE
K901008 · GEX
Lihtan Technologies, Inc.
General & Plastic Surgery · 59d
Cleared May 03, 1990
CHILDREN'S SUNGLASSES
K901468 · HQY
M. & S. Shillman, Inc.
Ophthalmic · 35d
Cleared May 03, 1990
FORTRESS COMMUTER FT (FOLDING TRANSPORT)
K901707 · ITI
Fortress, Inc.
Physical Medicine · 20d
Cleared May 03, 1990
INSTANT ICE PACK
K901834 · IMD
Impact Packaging Corp.
Physical Medicine · 9d
Cleared May 03, 1990
COAT-A-COUNT TOTAL IGE IRMA, CATALOG #IKIE1, IKIE2
K901859 · JHR
Diagnostic Products Corp.
Immunology · 9d
Cleared May 02, 1990
FRENTA(R) DUO-SET
K895246 · KNT
Delmed, Inc.
Gastroenterology & Urology · 254d