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
110401–110424 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 26, 1994
ORAL EASE AUTOMATIC FLOSSER/POWER BRUSH
K936076 · JEQ
Ohio Health Care Products, Inc.
Dental · 37d
Cleared Jan 25, 1994
COMPOUND BENZOIN TINCTURE USP FREPP
K920399 · KMF
Medi-Flex Hospital Products, Inc.
General & Plastic Surgery · 726d
Cleared Jan 25, 1994
COMPOUND BENZOIN TINCTURE USP SEPP
K923516 · KMF
Medi-Flex Hospital Products, Inc.
General & Plastic Surgery · 586d
Cleared Jan 25, 1994
P.F.C. MOD TOTAL KNEE/CONDYL 3 FEM COMP TIB INSERT
K924340 · JWH
Johnson & Johnson Orthopaedics, Inc.
Orthopedic · 515d
Cleared Jan 25, 1994
90DX MULTITEST METER, MODIFICATION
K925210 · FLB
Mesa Medical, Inc.
Gastroenterology & Urology · 475d
Cleared Jan 25, 1994
GLASSES MOLASSES
K930174 · HQZ
Arthur F. Kozakowski, Jr.
Ophthalmic · 377d
Cleared Jan 25, 1994
MEDIMAC BANDAGE
K930457 · KGX
Enquay Pharmaceutical
General & Plastic Surgery · 362d
Cleared Jan 25, 1994
TALIA LASER SLIT
K930518 · HJO
Talia Technology , Ltd.
Ophthalmic · 358d
Cleared Jan 25, 1994
PHILIPS GYROSCAN T5 II RELEASE 3
K930708 · LNH
Philips Medical Systems, Inc.
Radiology · 348d
Cleared Jan 25, 1994
TRICK MODULAR KNEE TIBIAL TRAY-POROUS
K931054 · JWH
Johnson & Johnson Orthopaedics, Inc.
Orthopedic · 330d
Cleared Jan 25, 1994
AOD4000 DISPOSABLE PAK
K931357 · HQC
American Optical Corp.
Ophthalmic · 314d
Cleared Jan 25, 1994
CARAPACE EPIDURAL BLOCK & SPINAL MYELOGRAM TRAYS
K931670 · CAZ
Carapace, Inc.
Anesthesiology · 294d
Cleared Jan 25, 1994
CARAPACE STERILE GAUZE TRAYS
K931759 · LRO
Carapace, Inc.
General & Plastic Surgery · 292d
Cleared Jan 25, 1994
CUSTOM PROCEDURE MEDICAL TRAY OR KIT
K931844 · LRO
Custom Medical Products, Ltd.
General & Plastic Surgery · 287d
Cleared Jan 25, 1994
DENTAL X-RAY UNIT
K932111 · EHD
Castellini S.P.A.
Radiology · 267d
Cleared Jan 25, 1994
MODIFIED SITE POWER HANDPIECE II
K932600 · EKX
Chiron Vision Corp.
Dental · 242d
Cleared Jan 25, 1994
ARTHREX AR-8200 SHAVER SYSTEM
K932699 · HWE
Arthrex, Inc.
Orthopedic · 236d
Cleared Jan 25, 1994
APEX OPTICAL IND. CO., EYE WEA MODELS
K932821 · HQZ
Apex Optical Ind. Co.
Ophthalmic · 230d
Cleared Jan 25, 1994
LAPORASCOPIC CANNULA SEAL
K933025 · GCJ
Li Medical Technologies, Inc.
General & Plastic Surgery · 217d
Cleared Jan 25, 1994
SPECTACLE FRAMES AND SUNGLASSES
K933189 · HQY
Eastern Breeze Intl. Co.
Ophthalmic · 209d
Cleared Jan 25, 1994
SUNGLASSES
K933223 · HQY
Rally Accessories, Inc.
Ophthalmic · 208d
Cleared Jan 25, 1994
MODIFICATION OF ANTERIOR SEGMENT ELECTRODES
K933527 · HWA
Mira, Inc.
Orthopedic · 189d
Cleared Jan 25, 1994
ENDOSTAR(TM) STYLET
K933598 · BSR
Fiberoptic Medical Products, Inc.
Anesthesiology · 183d
Cleared Jan 25, 1994
PHACOFRAGMENTOR TIP
K933627 · HQC
M. Imonti and Associates Inc.,
Ophthalmic · 182d