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
95449–95472 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 27, 1996
MINIFIX
K964094 · KTT
Ferguson Medical
Orthopedic · 47d
Cleared Nov 27, 1996
MICROSURGE LAPAROSCOPIC PERMACLIP CARTRIDGE WITH IMPLANTABLE CLIP
K964109 · FZP
Microsurge, Inc.
General & Plastic Surgery · 43d
Cleared Nov 27, 1996
PARACON PLUS FORMALIN - PCP-F, PARACON PLUS SAF - PCP-SAF AND PARACON PLUS MF...
K964144 · LIO
Para Scientific Co.
Microbiology · 41d
Cleared Nov 27, 1996
STARKEY A-13 SEQUEL PROGRAMMABLE, A-13 K-AMP PROGRAMMABLE AIR CONDUCTION...
K964214 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 36d
Cleared Nov 27, 1996
STARKEY CUSTOM SEQUEL PROGRAMMABLE AND K AMP PROGRAMMABLE AIR CONDUCTION...
K964244 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 34d
Cleared Nov 27, 1996
VITROS IMMUNODIAGNOSTICS PRODUCTS T3 UPTAKE REAGENT PACK (GEM.1025) AND T3...
K964308 · KHQ
Johnson & Johnson Clinical...
Chemistry · 29d
Cleared Nov 27, 1996
VITROS IMMUNODIAGNOSTICS PRODUCT - TOTAL T3 REAGENT PACK (GEM .101) AND TOTAL...
K964310 · CDP
Johnson & Johnson Clinical...
Chemistry · 29d
Cleared Nov 27, 1996
AIA-PACK FOLATE ASSAY
K964349 · CGN
Tosoh Medics, Inc.
Chemistry · 27d
Cleared Nov 27, 1996
PICCOLO K-AMP VC+, PICCOLO P-A1, PICCOLO P-AO AND PICCOLO ATC
K964451 · ESD
Rexton, Inc.
Ear, Nose, Throat · 21d
Cleared Nov 27, 1996
UNITRON MODEL SOUND F/XP +4
K964502 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 19d
Cleared Nov 27, 1996
UNITRON MODEL SOUND F/X +4
K964503 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 19d
Cleared Nov 27, 1996
UNITRON MODEL ICON AOHPL +4
K964504 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 19d
Cleared Nov 27, 1996
UNITRON MODEL ICON AOHP +4 (ICON AOHP +4)
K964508 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 19d
Cleared Nov 27, 1996
UNITRON MODEL ICON AOHPD +4 (ICON AOHPD +4)
K964510 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 19d
Cleared Nov 27, 1996
UNITRON MODEL SOUND F/XD +4 (SOUND F/XD +4)
K964511 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 19d
Cleared Nov 27, 1996
DAHLBERG HEARING AID WITH MULTI-CHANNEL COMPRESSION CIRCUIT
K964530 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 15d
Cleared Nov 27, 1996
RESOUND BT4 PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION
K964557 · ESD
Resound Corp.
Ear, Nose, Throat · 14d
Cleared Nov 26, 1996
DISPOSABLE SCALP VEIN INFUSION SET
K953252 · FOZ
Myco Medical Supplies, Inc.
General Hospital · 503d
Cleared Nov 26, 1996
KARL STORZ POINT COAGULATOR, SEMM CROCODILE FORCEPS, MYOMA ENUCLEATOR
K955756 · HGI
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 343d
Cleared Nov 26, 1996
TEST-MATE CHE CHOLINESTERASE TEST SYSTEM
K961656 · DIH
Eqm Research, Inc.
Toxicology · 210d
Cleared Nov 26, 1996
ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT
K962045 · CAH
Mallinckrodt Medical
General Hospital · 182d
Cleared Nov 26, 1996
STERILE AND NON-STERILE O.R. TOWELS, STERILE AND NON-STERILE X-RAY DETECTABLE...
K962205 · KKX
Medline Industries, Inc.
General Hospital · 172d
Cleared Nov 26, 1996
OSMOCYTE ULTRA/PE PILLOW WOUND DRESSING
K962623 · KMF
Procyte Corp.
General & Plastic Surgery · 144d
Cleared Nov 26, 1996
DEXIS MODEL 601 DENTAL ELECTRONIC IMAGING SYSTEM
K962631 · EHD
Fair Image, Inc.
Radiology · 144d