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
103633–103656 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 28, 1995
STREAK RETINOSCOPE RX-RP
K950795 · HKM
Neitz Instruments Company, Ltd.
Ophthalmic · 35d
Cleared Mar 28, 1995
HALOGEN OPHTHALMO-OTOSCOPE SET BX A - 134
K950797 · HLJ
Neitz Instruments Company, Ltd.
Ophthalmic · 35d
Cleared Mar 28, 1995
KARL STORZ FIBER OPTIC LIGH CABLES
K950811 · GCJ
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 34d
Cleared Mar 27, 1995
REMEDI HS DRUG PROFILING SYSTEM
K941596 · DNI
Bio-Rad
Toxicology · 360d
Cleared Mar 27, 1995
TDP THE SPECIAL ELECTROMAGNETIC THERAPEUTIC APPARATUS
K941675 · ILY
C.M.D. Acupuncture Center & Herbs Store
Physical Medicine · 356d
Cleared Mar 27, 1995
N LATEX FERRITIN
K950707 · DBF
Behring Diagnostics, Inc.
Immunology · 40d
Cleared Mar 27, 1995
OLYMPUS IGM IMMUNOTURBIDIMETRIC REAGENT
K950900 · CFQ
Olympus America, Inc.
Immunology · 27d
Cleared Mar 24, 1995
EMIT IIC CALIBRATORS
K935192 · DKB
Syva Co.
Chemistry · 514d
Cleared Mar 24, 1995
SPECIAL ELECTROMAGNETIC THERAPEUTIC APPARATUS
K935982 · ILY
C.M.D. Acupuncture Center
Physical Medicine · 465d
Cleared Mar 24, 1995
ENDOSCOPE SHEATH
K940028 · EOB
Xomed-Treace, Inc.
Ear, Nose, Throat · 445d
Cleared Mar 24, 1995
TOA MEDICAL ELECTRONICS CA-1000
K942096 · JPA
Sysmex Corp.
Hematology · 344d
Cleared Mar 24, 1995
TOA MEDICAL ELECTRONICS CA-5000
K942097 · JPA
Sysmex Corp.
Hematology · 344d
Cleared Mar 24, 1995
LIFESCAN SURESTEP BLOOD GLUCOSE MONITORING SYSTEM
K942455 · CGA
Lifescan, Inc.
Chemistry · 305d
Cleared Mar 24, 1995
LASEAWAY Q-SWITCHED ND:YAG LASER SYSTEM
K942622 · GEX
Mdi, Inc.
General & Plastic Surgery · 295d
Cleared Mar 24, 1995
IN VITRO DIAGNOSTIC URINE REAGENT STRIPS SET
K942648 · JIL
Teco Diagnostics
Chemistry · 294d
Cleared Mar 24, 1995
PRESSSION S III
K942796 · JOW
Chattanooga Group, Inc.
Cardiovascular · 283d
Cleared Mar 24, 1995
MICROSAMPLE COAGULATION ANALYZER
K943153 · GKP
Bio/Data Corp.
Hematology · 267d
Cleared Mar 24, 1995
ITI TRANSVERSAL SCREWING SYSTEM
K943720 · DZE
The Straumann Co.
Dental · 235d
Cleared Mar 24, 1995
PULSE OXIMETER MODEL 305
K943842 · DQA
Palco Laboratories, Inc.
Anesthesiology · 231d
Cleared Mar 24, 1995
HEPARIN ASSAY CARTRIDGES AND CONTROLS
K944115 · GFT
Medtronic Hemotec, Inc.
Hematology · 213d
Cleared Mar 24, 1995
OLYMPUS INORGANIC PHOSPHORUS REAGENT
K944768 · CEO
Olympus America, Inc.
Chemistry · 178d
Cleared Mar 24, 1995
MITEK G III ANCHOR, MITEK LS ANCHOR
K944936 · JDR
Mitek Surgical Products, Inc.
Orthopedic · 169d
Cleared Mar 24, 1995
PANOPLEX HYDROGEL WOUND DRESSING
K945005 · MGQ
Sage Pharmaceuticals, Inc.
General & Plastic Surgery · 162d
Cleared Mar 24, 1995
HOSPITAL BROAD BAND CLEANDR - DISINFECTANT-DEODORANT
K946078 · LRJ
Clariant Corporation
General Hospital · 101d