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
139609–139632 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 20, 1987
SYNTRON BIORESEARCH EZ CHECK HCG PREGNANCY TEST
K870751 · JHI
Syntron Bioresearch, Inc.
Chemistry · 84d
Cleared May 20, 1987
FAST-PATCH(TM)
K871224 · LDD
Physio-Control Corp.
Cardiovascular · 54d
Cleared May 20, 1987
FOLLICLE STIMULATING HORMONE (HFSH)
K871317 · CGJ
Immuchem Corp.
Chemistry · 48d
Cleared May 20, 1987
IONOCAL
K871562 · EMA
Foremost Dental Mfg., Inc.
Dental · 28d
Cleared May 20, 1987
URINOSCOPY FUNNEL
K871671 · GHO
Portable Medical Laboratories, Inc.
Hematology · 22d
Cleared May 20, 1987
TYTEM(R) REAGENT DISPENSER
K871687 · JQW
Medical Laboratory Automation...
Chemistry · 21d
Cleared May 20, 1987
ARYLSULFATASE BROTH
K871701 · JSH
Bd Becton Dickinson Vacutainer...
Microbiology · 19d
Cleared May 20, 1987
MRS AGAR AND MRS BROTH
K871702 · JSJ
Bd Becton Dickinson Vacutainer...
Microbiology · 19d
Cleared May 20, 1987
BLOXOM IRRIGATOR
K871791 · EXD
I.B. Bloxom C/O Hogan & Hartson
Gastroenterology & Urology · 13d
Cleared May 19, 1987
HR-5000 ELECTROSURGICAL DEVICE
K864869 · KCW
Ime Co. , Ltd.
General & Plastic Surgery · 158d
Cleared May 19, 1987
LUTEMOLL (BIOPLAST)
K871038 · EBI
B. L. Dental Co.
Dental · 63d
Cleared May 19, 1987
DMI AMBULATORY HOLTER MONITOR
K871045 · DSH
Diagnostic Medical Instruments
Cardiovascular · 63d
Cleared May 19, 1987
TELSTAR MODEL 0/3 HEARING AID
K871519 · ESD
Telstar Electronics, Inc.
Ear, Nose, Throat · 29d
Cleared May 19, 1987
DAHLBERG MODEL UL IN-THE-EAR HEARING AID
K871525 · ESD
Dahlberg Electronics, Inc.
Ear, Nose, Throat · 29d
Cleared May 19, 1987
BABYSET(TM) MODIFIED JACKSON-REES CIRCUIT W/VALVE
K871669 · CAI
Life Design Systems, Inc.
Anesthesiology · 21d
Cleared May 19, 1987
MCCONNELL ORTHOPEDIC STERILE ARTICULATED ARM
K871703 · FWZ
Mcconnell Orthopedic
General & Plastic Surgery · 18d
Cleared May 19, 1987
MCCONNELL ORTHOPEDIC UNIVERSAL POSITIONER (MUP)
K871803 · FWZ
Mcconnell Orthopedic
General & Plastic Surgery · 11d
Cleared May 19, 1987
MCCONNEL ORTHOPEDIC ARTHROSCOPY SUPPORT ASSEMBLY
K871804 · FWZ
Mcconnell Orthopedic
General & Plastic Surgery · 11d
Cleared May 19, 1987
MCCONNELL ORTHOPEDIC STERILE UPRIGHT SUPPORT
K871805 · FWZ
Mcconnell Orthopedic
General & Plastic Surgery · 11d
Cleared May 18, 1987
CYCLO-BRUSH
K870782 · HHT
Medline Industries, Inc.
Obstetrics & Gynecology · 81d
Cleared May 18, 1987
MODEL 20-C WITH AN SA-20B/U OPT. ATTACH. HEMORRHO.
K871029 · LNK
Directed Energy, Inc.
Gastroenterology & Urology · 63d
Cleared May 18, 1987
MODEL 20-C WITH AN SA-20A/U OPT. ATTACH. HEMORRHO.
K871032 · LNK
Directed Energy, Inc.
Gastroenterology & Urology · 63d
Cleared May 18, 1987
TOPCON COMPUTERIZED TONOMETER CT-10
K871335 · HKX
Topcon Instrument Corporation of America
Ophthalmic · 45d
Cleared May 18, 1987
KIRSCHNER MODULAR HIP SYSTEM
K871401 · JDI
Kirschner Medical Corp.
Orthopedic · 40d