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
115297–115320 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 16, 1993
CORNEAL TOPOGRAPHY SYSTEM
K923435 · HLQ
Par Microsystems Corp.
Ophthalmic · 218d
Cleared Feb 16, 1993
BEAUSOLEIL FRAME
K923500 · HQZ
Oliver Peoples, Inc.
Ophthalmic · 216d
Cleared Feb 16, 1993
LEMAITRE RETROGRADE VALVULOTOME
K924171 · MGZ
Vascutech, Inc.
Cardiovascular · 182d
Cleared Feb 16, 1993
MEDI-PLINTH
K924905 · INQ
Medi-Man Rehabilitation Products, Inc.
Physical Medicine · 140d
Cleared Feb 16, 1993
CALMPS: BONE, MASTIN, LEWIN, BRAND
K930028 · LXH
Thomasville Medical Assoc.
Orthopedic · 42d
Cleared Feb 12, 1993
AMERICAN ARTIFICIAL LARYNX
K914816 · ESE
Ultravoice, Ltd.
Ear, Nose, Throat · 476d
Cleared Feb 12, 1993
HPD HEATER BASES
K914994 · BZE
Hpd Medical, Inc.
Anesthesiology · 463d
Cleared Feb 12, 1993
CRK CONDYLAR RESURFACING TOTAL KNEE
K915584 · JWH
Implantology Corp.
Orthopedic · 427d
Cleared Feb 12, 1993
HOTPAD
K915876 · IME
Ten Comfort Corp.
Physical Medicine · 421d
Cleared Feb 12, 1993
PCX 1050HF RADIOGRAPHIC X-RAY GENERATOR
K920349 · IZO
Control-X, Inc.
Radiology · 385d
Cleared Feb 12, 1993
PCX 650HF RADIOGRAPHIC X-RAY
K920351 · IZO
Control-X, Inc.
Radiology · 385d
Cleared Feb 12, 1993
VIDAS CMV IGG ASSAY
K920661 · LFZ
Vitek Systems, Inc.
Microbiology · 365d
Cleared Feb 12, 1993
NYCOPLASTIN
K920767 · GJS
Nycomed Pharma AS
Hematology · 359d
Cleared Feb 12, 1993
TITANIUM VENTILATION TUBES
K921923 · ETD
Exmoor Plastics , Ltd.
Ear, Nose, Throat · 310d
Cleared Feb 12, 1993
ANGIOGRAPHIC CATHETER -- MODIFICATION
K922101 · DQO
Interventional Therapeutics Corp.
Cardiovascular · 282d
Cleared Feb 12, 1993
FLOW CONTROL VALVE, CAT. NO. ACV-38
K922356 · MJJ
American Omni Medical, Inc.
Cardiovascular · 269d
Cleared Feb 12, 1993
AUSTIN-MOORE TYPE HIP PROSTHESIS
K922860 · JDI
Osteo Technology, Inc.
Orthopedic · 253d
Cleared Feb 12, 1993
CHARNLEY TYPE HIP PROTHESIS
K922862 · JDI
Osteo Technology, Inc.
Orthopedic · 253d
Cleared Feb 12, 1993
EUROSTEM HIP PROTHESIS SYSTEM
K922863 · JDI
Osteo Technology, Inc.
Orthopedic · 253d
Cleared Feb 12, 1993
MUELLER TYPE FEMORAL STEM
K922864 · JDI
Osteo Technology, Inc.
Orthopedic · 253d
Cleared Feb 12, 1993
OTI BONE PLUG
K922866 · JDI
Osteo Technology, Inc.
Orthopedic · 253d
Cleared Feb 12, 1993
THOMPSON TYPE HIP PROTHESIS
K922868 · KWA
Osteo Technology, Inc.
Orthopedic · 253d
Cleared Feb 12, 1993
UNIFIT FEMORAL STEM
K922871 · JDI
Osteo Technology, Inc.
Orthopedic · 253d
Cleared Feb 12, 1993
QUICKLAMP SYSTEM
K923085 · DXC
Disco, Inc.
Cardiovascular · 232d