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
125809–125832 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 29, 1990
AUDIOTONE MODEL A-52S BEHIND-THE-EAR HEARING INST.
K901745 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 42d
Cleared May 29, 1990
AUDIOTONE ITE HEARING AID MODEL ZD (XT)
K901746 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 42d
Cleared May 29, 1990
AUDIOTONE ITE HEARING AID MODEL ZG (MIRAGE)
K901747 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 42d
Cleared May 29, 1990
AUDIOTONE ITE HEARING AID MODEL ZA (MICRO)
K901783 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 42d
Cleared May 29, 1990
KTP/532 (TM) SURGICAL LASER
K901943 · GEX
Laserscope
General & Plastic Surgery · 29d
Cleared May 29, 1990
CONTROL 1 ENVIRONMENTAL CONTROL
K902206 · ILQ
Prentke Romich Co.
Physical Medicine · 13d
Cleared May 25, 1990
EOS INLAY MATERIAL
K896469 · EBF
Ivoclar North America, Inc.
Dental · 193d
Cleared May 25, 1990
OCULAR OCCLUDER
K900942 · HOY
Microdynamics
Ophthalmic · 86d
Cleared May 25, 1990
UNIVERSUM
K900946 · LBH
Scientific Pharmaceuticals, Inc.
Dental · 85d
Cleared May 25, 1990
ORTHO CORRECTION REAGENTS
K901327 · GJT
Ortho Diagnostic Systems, Inc.
Hematology · 65d
Cleared May 25, 1990
TOPOGRAPHIC MODELING SYSTEM
K901363 · HLQ
Computed Anatomy, Inc.
Ophthalmic · 63d
Cleared May 25, 1990
CASCADE 480(TM) AUTOMATED COAGULATION ANALY. 1430
K901380 · GKP
Helena Laboratories
Hematology · 64d
Cleared May 24, 1990
MODIFIED MINIMED III INFUSION PUMP
K895436 · FRN
Medtronic Minimed
General Hospital · 289d
Cleared May 24, 1990
DSL C-PEPTIDE RIA (DSL #7000)
K896420 · JKD
Diagnostic Systems Laboratories, Inc.
Chemistry · 197d
Cleared May 24, 1990
IM COLLAGEN SHIELD
K896449 · MOE
Intermedical, Inc.
Ophthalmic · 196d
Cleared May 24, 1990
ASI TCU PROSTATIC URETHROPLASTY CATHETER & ACCESS.
K896713 · KOE
Advanced Surgical Intervention, Inc.
Gastroenterology & Urology · 176d
Cleared May 24, 1990
IRRIGATION TRAY
K896800 · KYZ
Westmark, Sterile Packing Systems,...
General Hospital · 174d
Cleared May 24, 1990
NIIC MODEL: DX901 ASPIRATION SYSTEM
K900185 · JFL
Niic U.S.A., Inc.
Chemistry · 128d
Cleared May 24, 1990
DISTRAC(TM) TABLE
K900475 · ITH
Lossing Orthopedic, Inc.
Physical Medicine · 112d
Cleared May 24, 1990
POLY-OP (TM)
K900759 · OCF
Nu-Gyn-Tek, Inc.
Neurology · 97d
Cleared May 24, 1990
SYLVAN PEDIASCAN 200 TRANSILLUMINATOR
K901309 · HJN
Sylvan Corp.
Ophthalmic · 65d
Cleared May 24, 1990
SURE-STOP TRANSBRONCHIAL ASPIRATION NEEDLE
K901438 · GAA
Telemed Systems, Inc.
General & Plastic Surgery · 59d
Cleared May 24, 1990
QUICK CHEM II
K901695 · JJQ
Seradyn, Inc.
Chemistry · 44d
Cleared May 24, 1990
KLEIN MICRO-CANNULA(TM)
K901717 · GEA
Jeff Klein Surgical, Inc.
General & Plastic Surgery · 41d