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
113953–113976 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 31, 1993
SUPERSTAR
K930762 · EJT
Jelenko Co.
Dental · 47d
Cleared Mar 30, 1993
PS MEDICAL CSF-ACCESS DEVICE
K913412 · JXG
Pudenz-Schulte Medical Research Corp.
Neurology · 608d
Cleared Mar 30, 1993
AESCULAP TROCAR INSTRUMENT SET
K922797 · GCJ
Aesculap, Inc.
General & Plastic Surgery · 294d
Cleared Mar 30, 1993
PORT-XD
K923360 · EHD
Mobile Dental Equipment Corp.
Radiology · 265d
Cleared Mar 30, 1993
TROCAR
K924058 · GCJ
Endo Technic Corp.
General & Plastic Surgery · 230d
Cleared Mar 30, 1993
MEND APC
K924094 · JEA
Mend Technologies, Inc.
General & Plastic Surgery · 229d
Cleared Mar 30, 1993
CODMAN SOFWIRE(TM) KIT
K926116 · JDQ
Codman & Shurtleff, Inc.
Orthopedic · 117d
Cleared Mar 30, 1993
DURACON UNICOMPARTMENTAL KNEE SYSTEM
K926231 · HSX
Howmedica Corp.
Orthopedic · 109d
Cleared Mar 30, 1993
SCHUL-TEC IMMOBILIZER
K926291 · IQK
Medical Emergency Support Equipment
Physical Medicine · 106d
Cleared Mar 30, 1993
MAMMOTEST PRODUCT, MODIFICATION
K926575 · EHD
Fischer Imaging Corp.
Radiology · 119d
Cleared Mar 29, 1993
OLYMPUS-KEYMED DISINFECTANT FUME EXTRACTOR DFE-20
K921179 · FEB
Keymed, Inc.
General Hospital · 385d
Cleared Mar 29, 1993
TELEMEDIC TELERADIOLOGY SYSTEM
K921185 · LMD
Meditron Corp.
Radiology · 385d
Cleared Mar 29, 1993
HOSPITAL KIT GP 103
K922127 · MDM
Savoy Medical Supply Co., Inc.
General & Plastic Surgery · 327d
Cleared Mar 29, 1993
MIS
K923543 · HLJ
Ceram Optec, Inc.
Ophthalmic · 256d
Cleared Mar 29, 1993
NIDEK MODEL VST-4000
K924353 · HQE
Nidek, Inc.
Ophthalmic · 213d
Cleared Mar 29, 1993
BIOPSY FORCEPS, ELECTRIC
K925361 · KGE
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 158d
Cleared Mar 29, 1993
LIBERATOR
K925387 · ILQ
Prentke Romich Co.
Physical Medicine · 154d
Cleared Mar 29, 1993
INTERFERENTIAL STIMULATOR MODEL IMF4150/A
K925687 · LIH
Biomedical Life Systems, Inc.
Neurology · 137d
Cleared Mar 29, 1993
TRACE MICROPROTEIN REAGENT
K925794 · JGQ
Trace America, Inc.
Chemistry · 133d
Cleared Mar 29, 1993
VISTA PROLACTIN ASSAY
K926386 · CFT
Syva Co.
Chemistry · 97d
Cleared Mar 29, 1993
VARIANT(TM) HEMOGLOBIN A 1C PROGRAM
K926469 · LCP
Bio-Rad
Hematology · 91d
Cleared Mar 29, 1993
MODEL 330 SCREENING AUDIO METER, MODIFIED
K926574 · GWJ
Virtual Corp.
Neurology · 89d
Cleared Mar 29, 1993
TREATMENT TABLE, MODEL #825-100
K930262 · INO
Biodan Medical Systems, Ltd.
Physical Medicine · 69d
Cleared Mar 29, 1993
BNOS MICROVENT(TM), MODEL AC AND MODEL AO
K930533 · BZT
Bnos Meditech, Ltd.
Anesthesiology · 55d