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

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175,820 results
102817–102840 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 12, 1995
CAP SAFE SYSTEM
K943057 · FMI
Medical Safety Solutions
General Hospital · 407d
Cleared Jul 12, 1995
BELTONE PERSONAL HEARING SCREENER
K943616 · EWO
Beltone Electronics Corp.
Ear, Nose, Throat · 350d
Cleared Jul 12, 1995
BONE FIXATION NAIL
K943855 · JDS
Acu Med, Inc.
Orthopedic · 338d
Cleared Jul 12, 1995
WELLHOFER WP700 V. 3.2
K945321 · IYE
Medical Physics Instrumentation, Inc.
Radiology · 253d
Cleared Jul 12, 1995
LUHR MANDIBULAR/SMALL FIXATION IMPLANTS
K950595 · JEY
Howmedica Corp.
Dental · 153d
Cleared Jul 12, 1995
KARL STORZ HOK NEEDLE HOLDERS, FORCEPS FOR SUTURING, SUTURE SCISSORS, TISSUE...
K950962 · HET
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 132d
Cleared Jul 12, 1995
MED-TEC TESTICULAR SEPARATOR
K951679 · IYE
Medtec, Inc.
Radiology · 92d
Cleared Jul 12, 1995
A GEL WOUND DRESSING
K951862 · MGQ
Polymedica Industries, Inc.
General & Plastic Surgery · 82d
Cleared Jul 12, 1995
DICOMIT
K951925 · IYO
Dicomit Imaging Systems Corp.
Radiology · 78d
Cleared Jul 12, 1995
MED-TEC RADIO THERAPY TREATMENT CHAIR
K951947 · IYE
Medtec, Inc.
Radiology · 77d
Cleared Jul 12, 1995
STERIGAUZE WET DRESSING
K952420 · KMF
Acacia Laboratories, Inc.
General & Plastic Surgery · 50d
Cleared Jul 12, 1995
SHIMADZU X-RAY HIGH VILTAGE GENERATOR AHD150G
K952822 · IZO
Shimadzu Corp.
Radiology · 22d
Cleared Jul 12, 1995
SUNGLASSES
K952890 · HQY
Isohyper
Ophthalmic · 19d
Cleared Jul 12, 1995
READY NURSE SYSTEM (RNS) TRACH CARE KIT
K952925 · LRQ
Contour Fabricators of Florida, Inc.
General & Plastic Surgery · 16d
Cleared Jul 12, 1995
METAL FRAM WITH POLYCARBONATE LENS
K953002 · HQY
Nakanishi Optical Products Corp.
Ophthalmic · 14d
Cleared Jul 12, 1995
DISPOSABLE & REUSABLE SURGICAL CUTTING TOOLS
K953012 · GFA
Boston Surgical Products, Inc.
General & Plastic Surgery · 14d
Cleared Jul 12, 1995
SLIT LAMP AIA 11
K953030 · HJO
Naveen Intl., Inc.
Ophthalmic · 13d
Cleared Jul 11, 1995
VISUWELL SYPHILIS ANTIBODY
K932453 · LIP
Biomira Diagnostics, Inc.
Microbiology · 782d
Cleared Jul 11, 1995
CUSA(R) SYST 200CT/200T ULTRA ASPIR LAP/CEM ACCESS
K934628 · LFL
Valleylab, Inc.
General & Plastic Surgery · 664d
Cleared Jul 11, 1995
FOUNDATION POROUS STEM
K935263 · JDI
Encore Orthopedics, Inc.
Orthopedic · 615d
Cleared Jul 11, 1995
MILLER/GALANTE PRECOAT UNICOMPARTMENTAL KNEE SYSTEM
K942263 · HSX
Zimmer, Inc.
Orthopedic · 428d
Cleared Jul 11, 1995
J.B.S. CERVICAL SPINE SYSTEM
K942432 · KWP
J.B.S., S.A.
Orthopedic · 417d
Cleared Jul 11, 1995
ANSPACH SUTURE ANCHOR
K945525 · HWC
The Anspach Effort, Inc.
Orthopedic · 243d
Cleared Jul 11, 1995
SAFETY PLUS
K945843 · EJI
Arent Fox
Dental · 223d