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
112273–112296 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 19, 1993
CLINITEK ATLAS AUTOMATED URINE CHEMISTRY SYSTEM
K932674 · KQO
Miles Inc., Dental Products
Chemistry · 78d
Cleared Aug 19, 1993
BELTONE PRIMA 2000
K932703 · ESD
Beltone Electronics Corp.
Ear, Nose, Throat · 77d
Cleared Aug 19, 1993
MICRINS CONTRAST BACKGROUND MATERIAL
K933310 · EPT
Micrins Surgical, Inc.
General & Plastic Surgery · 43d
Cleared Aug 19, 1993
CIBA CORNING 300 SERIES SYSTEM
K933373 · JGS
Ciba Corning Diagnostics Corp.
Chemistry · 38d
Cleared Aug 18, 1993
TRACHEOSTOMY CARE TRAY
K923156 · JOH
Orion Life Systems, Inc.
Anesthesiology · 415d
Cleared Aug 18, 1993
LINAC-BASED STEROTACTIC RADIOSURGERY
K923522 · IYE
Radionics Software Applications, Inc.
Radiology · 398d
Cleared Aug 18, 1993
THE KARL STORZ 11274 SERIES FLEXIBLE FIBERSCOPE
K925128 · FGB
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 309d
Cleared Aug 18, 1993
ACTION MEDTEK FACE SHIELD
K926438 · LYU
Action Eyewear Corp.
General Hospital · 238d
Cleared Aug 18, 1993
IMAGYN MEDICAL VIDEOSCOPY SYST W/IRRIG PUMP & ACCE
K931518 · GCJ
Imagyn Medical, Inc.
General & Plastic Surgery · 145d
Cleared Aug 18, 1993
SURGICAL TROCAR AND TROCAR SLEEVE
K932229 · GCJ
Origin Medsystems, Inc.
General & Plastic Surgery · 103d
Cleared Aug 18, 1993
PASCO MIC AND MIC/ID PANELS
K932917 · JWY
Pasco Laboratories, Inc.
Microbiology · 63d
Cleared Aug 18, 1993
EASY-ON
K932998 · GES
Devon Industries, Inc.
General & Plastic Surgery · 61d
Cleared Aug 17, 1993
FIBER OPTIC ENDOSCOPE
K921918 · GCM
Electro Fiberoptics Corp.
Gastroenterology & Urology · 481d
Cleared Aug 17, 1993
XOMED-TREACE EMG ENDOTRACHEAL TUBEEN
K925640 · ETN
Xomed-Treace, Inc.
Ear, Nose, Throat · 281d
Cleared Aug 17, 1993
HGM ASPIRATING ENDOOCULAR(TM) PROBE
K925663 · HQF
Hgm, Inc.
Ophthalmic · 280d
Cleared Aug 17, 1993
SOLSTAR BRILLENMODE SUNGLASSES
K930562 · HQY
Solstar Produktions GmbH
Ophthalmic · 195d
Cleared Aug 17, 1993
SCIMED 6 FR., 7 FR., AND 8 FR.,TRIGUIDE GUIDING
K932420 · DQO
Scimed Life Systems, Inc.
Cardiovascular · 90d
Cleared Aug 17, 1993
MEROCEL MEROSPLINT
K933152 · LYA
Merocel Corp.
Ear, Nose, Throat · 49d
Cleared Aug 16, 1993
POLY-MED DISP. PERS. PROT. GOWN APRON & SHOECOVERS
K925077 · FYC
Medtek Development Corp.
General Hospital · 313d
Cleared Aug 16, 1993
TRILOGY INFUSION PUMP
K925311 · FRN
Ivion Corp.
General Hospital · 299d
Cleared Aug 16, 1993
MPC-1000 INJECTION CAP/PLUG
K925927 · FPA
Molded Products, Inc.
General Hospital · 266d
Cleared Aug 16, 1993
MPC-150 MALE TO MALE LUER ADAPTER
K925930 · FPA
Molded Products, Inc.
General Hospital · 266d
Cleared Aug 16, 1993
3M MODEL 280RT RATE TAPER INFUSION PUMP
K926058 · FRW
3M Health Care, Ltd.
General Hospital · 258d
Cleared Aug 16, 1993
3M MODEL 200RT RATE TAPER INFUSION PUMP
K926059 · FRW
3M Health Care, Ltd.
General Hospital · 258d