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
107281–107304 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 25, 1994
NON-PRESCRIPTION SUNGLASSES
K942673 · HQY
Angel Eyewear
Ophthalmic · 49d
Cleared Jul 25, 1994
SPECTACLE FRAMES
K942750 · HQZ
Aspex Eyewear, Inc.
Ophthalmic · 45d
Cleared Jul 25, 1994
NIL
K942755 · HQY
Ever Great International , Ltd.
Ophthalmic · 45d
Cleared Jul 25, 1994
A-200 MULTI-USE AIRWAY ADAPTER
K942772 · CCK
Pryon Corp.
Anesthesiology · 42d
Cleared Jul 25, 1994
ORVIS WORLD FINEST POLARIZED CLIP ONS
K942952 · HQY
The Orvis Co., Inc.
Ophthalmic · 32d
Cleared Jul 25, 1994
SPECTACLE FRAME
K943084 · HQZ
Samil Enterprise Co.
Ophthalmic · 27d
Cleared Jul 25, 1994
AUTO SUTURE PITUITARY SPINAL RONGEUR
K943115 · HAO
United States Surgical, A Division of...
Neurology · 28d
Cleared Jul 22, 1994
ULTRASOUND TRANSUCER, MODEL US915 -- MODIFICATION
K923335 · HGL
Advanced Medical Systems, Inc.
Obstetrics & Gynecology · 774d
Cleared Jul 22, 1994
VIVOPERL-PE, VIVAPERL-PE ORTHOTYP/ORTHOTYP A
K930835 · ELL
Ivoclar North America, Inc.
Dental · 520d
Cleared Jul 22, 1994
MITEK GIII ANCHOR
K931782 · JDR
Mitek Surgical Products, Inc.
Orthopedic · 469d
Cleared Jul 22, 1994
FOUNDATION METAL-BACKED PATELLA
K932246 · JWH
Encore Orthopedics, Inc.
Orthopedic · 438d
Cleared Jul 22, 1994
FOUNDATION MODULAR TIBIAL BASEPLATE
K932425 · JWH
Encore Orthopedics, Inc.
Orthopedic · 429d
Cleared Jul 22, 1994
TEMPOARY POLYCARBONATE CROWNS
K932759 · ELZ
South American Dental Exporting Corp.
Dental · 409d
Cleared Jul 22, 1994
BRAINLAB LINAC HARDWARE
K934657 · IYE
Brainlab Med. Computersysteme GmbH
Radiology · 304d
Cleared Jul 22, 1994
UFC HIP STEM COMPONENTS: HYDROXYLAPATITE COATED
K934729 · MEH
Implantology Corp.
Orthopedic · 296d
Cleared Jul 22, 1994
ETEX HA HIP REPLACEMENT SYSTEM
K935696 · MEH
Etex Corp.
Orthopedic · 234d
Cleared Jul 22, 1994
ODYSSEY TAN 2000
K936314 · LEJ
Fitness TO Go, Inc.
General & Plastic Surgery · 214d
Cleared Jul 22, 1994
INNERVISION INC. LAPAROSCOPIC HAND INSTRUMENTS
K940718 · HET
Innervision, Inc.
Obstetrics & Gynecology · 154d
Cleared Jul 22, 1994
SUSTAIN HEX HA-COATED CYLINDER ENDOSSEOUS IMPLANT SYSTEM
K941554 · DZE
Lifecore Biomedical, Inc.
Dental · 114d
Cleared Jul 22, 1994
EMPTY, SOLUTION TRANSFER CONTAINER WITH DETATCHABLE LEG SET
K941731 · KPE
Incutech, Inc.
General Hospital · 106d
Cleared Jul 22, 1994
ORTHOCENT: LIQUID AND POWDER
K942665 · EMA
Dentauraum, Inc.
Dental · 46d
Cleared Jul 22, 1994
O-TRAY IMPRESSION TRAYS
K942668 · EHY
Dentauraum, Inc.
Dental · 46d
Cleared Jul 22, 1994
ARGESOL LO
K942929 · EJT
Argen Precious Metals, Inc.
Dental · 30d
Cleared Jul 22, 1994
ARGESOL-NOVASOL
K942943 · EJT
Argen Precious Metals, Inc.
Dental · 30d