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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
163273–163296 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jun 16, 1981
CARDIFF ALDASORBER SYSTEM
K811703
William Harvey Life Products Corp.
Cardiovascular
Cleared Jun 15, 1981
CORB TM COUNTERROTATING BIOPSY NEEDLE
K811005 · HSZ
Zimmer, Inc.
Orthopedic · 62d
Cleared Jun 12, 1981
FIRM-A-TRON
K810634 · IPF
Biotron , Ltd.
Physical Medicine · 94d
Cleared Jun 12, 1981
HY-BOND POLYCARBOXYLATE CEMENT
K810764 · EMA
Shofu Dental Corp.
Dental · 81d
Cleared Jun 12, 1981
HY-BOND ZINC PHOSPHATE CEMENT
K810765 · EMA
Shofu Dental Corp.
Dental · 81d
Cleared Jun 12, 1981
INSTAFIL
K810795 · KPE
Instafil, Inc.
Chemistry · 81d