Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
164113–164136 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 16, 1981
GLASS VIALS
K811269 · KPE
Medi-Plast Intl., Inc.
General Hospital · 42d
Cleared Jun 16, 1981
HEARING AID MODEL E1-P
K811285 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 39d
Cleared Jun 16, 1981
HEARING AID MODEL E1-PL
K811286 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 39d
Cleared Jun 16, 1981
ALTRACLUDE
K811303 · KDC
R&H Medical, Inc.
General & Plastic Surgery · 36d
Cleared Jun 16, 1981
BEHIND-THE-EAR HEARING AID
K811344 · ESD
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 35d
Cleared Jun 16, 1981
COLTENE DRS DENTAL RESTORATIVE SYSTEM
K811363 · EBF
Coltene, Inc.
Dental · 33d
Cleared Jun 16, 1981
PARA-PAK
K811377 · JTN
Meridian Diagnostics, Inc.
Microbiology · 32d
Cleared Jun 16, 1981
LAB-TEK JEMBEC G.C. CULTURE SYSTEM
K811382 · JTY
Miles Laboratories, Inc.
Microbiology · 32d
Cleared Jun 16, 1981
CCS100 CRYOSURGICAL SYSTEM
K811390 · GEH
Frigitronics of Connecticut, Inc.
General & Plastic Surgery · 29d
Cleared Jun 16, 1981
BA-93
K811407 · EJH
Deringer-Ney, Inc.
Dental · 28d
Cleared Jun 16, 1981
NEISSERIA-KWIK
K811412 · JSX
Windsor Laboratories, Inc.
Chemistry · 28d
Cleared Jun 16, 1981
MINERALS MODIFIED MED. BASE & SOD. GLUT.
K811420 · JSI
Oxoid U.S.A., Inc.
Chemistry · 27d
Cleared Jun 16, 1981
NORTHWESTERN VOICE RESTORATION KIT
K811428 · KAC
Universal Prosthetics, Inc.
Ear, Nose, Throat · 25d
Cleared Jun 16, 1981
SCRIPPSERA COMPLEMENT CONTROL SERA
K811433 · DHL
Scripps-Miles, Inc.
Immunology · 25d
Cleared Jun 16, 1981
ENHANCE DENTAL RESTORATIVE
K811443 · EBF
Johnson & Johnson Professionals, Inc.
Dental · 25d
Cleared Jun 16, 1981
ANIS GUIDING CANNULA
K811455 · HMX
American V. Mueller
Ophthalmic · 25d
Cleared Jun 16, 1981
STIM STAND
K811483 · ILP
Fred Sammons, Inc.
Physical Medicine · 21d
Cleared Jun 16, 1981
SEATING STOOLS
K811484 · INN
Fred Sammons, Inc.
Physical Medicine · 21d
Cleared Jun 16, 1981
WALKER/CRUTCH BAG
K811485 · ITJ
Fred Sammons, Inc.
Physical Medicine · 21d
Cleared Jun 16, 1981
WHEELCHAIR RAMPS
K811486 · KNO
Fred Sammons, Inc.
Physical Medicine · 21d
Cleared Jun 16, 1981
LUMBO-SACRAL FLEXION ORTHOSIS
K811494 · IPY
Surgical Appliance Industries, Inc.
Physical Medicine · 20d
Cleared Jun 16, 1981
GOTTSCHALK NASOSTAT SLIM LINE, ADULT/SM.
K811496 · EMX
Narco Scientific
Ear, Nose, Throat · 20d
Cleared Jun 16, 1981
AUTO-TYMPANIGRAPH (TA-5A)
K811509 · ETY
Teledyne Avionics Div. of Teledyne
Ear, Nose, Throat · 20d
Cleared Jun 16, 1981
CC-103
K811527 · DSI
Anthro-Metrics Corp.
Cardiovascular · 15d