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
139489–139512 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 29, 1987
ADAPTALITE* PORCELAIN VENEER CEMENTATION SYSTEM
K871295 · EBF
Johnson & Johnson Professionals, Inc.
Dental · 59d
Cleared May 29, 1987
CHECK-MATE AND CHECK-MATE [+]
K871359 · EFW
Veritech, Inc.
Dental · 53d
Cleared May 29, 1987
BREATHING CIRCUIT
K871386 · CAI
Dryden Corp.
Anesthesiology · 52d
Cleared May 29, 1987
SECOND NATURE(TM)
K871387 · KNX
Advanced Clinical Products, Inc.
Gastroenterology & Urology · 52d
Cleared May 29, 1987
PPG BIOMEDICAL VENTILATOR MODEL AV 400
K871433 · CBK
Ppg Industries, Inc.
Anesthesiology · 46d
Cleared May 29, 1987
FIRST AID KIT, EYE DRESSING
K871457 · LRR
Fraass Survival Systems, Inc.
General & Plastic Surgery · 46d
Cleared May 29, 1987
CLASSIC 70 LENS
K871649 · HQC
Korea Asahi Optical Co., Ltd.
Ophthalmic · 30d
Cleared May 29, 1987
SPECTACLE FRAME - DANIELLE
K871688 · HQZ
Roseburg SA
Ophthalmic · 30d
Cleared May 29, 1987
SPECTACLE FRAME - LORRAINE
K871689 · HQZ
Roseburg SA
Ophthalmic · 30d
Cleared May 29, 1987
DIGISPOT IMAGER
K871778 · LMC
Siemens Gammasonics, Inc.
Radiology · 23d
Cleared May 29, 1987
NOVAPATH C. TRACHOMATIS DIRECT SPEC COLLECTION KIT
K871860 · LIO
Bio-Rad
Microbiology · 16d
Cleared May 29, 1987
THE F SPOON HAND HELD FLUOROSCOPIC COMPRESSION
K871911 · JAA
F. Spoon Co.
Radiology · 11d
Cleared May 29, 1987
MICROLAB AT
K871945 · JTC
Hamilton Co.
Microbiology · 10d
Cleared May 28, 1987
ARTERIAL BLOOD GASSING MONITORING SYSTEM (ABG)
K870016 · DTB
Migada, Ltd.
Cardiovascular · 146d
Cleared May 28, 1987
AFFINITY (TM) HCG IMMUNIT (TM)
K870627 · JHI
Bd Becton Dickinson Vacutainer...
Chemistry · 104d
Cleared May 28, 1987
CIBA CORNING MODEL 664/FAST 4 SYSTEM
K871028 · JGS
Ciba Corning Diagnostics Corp.
Chemistry · 73d
Cleared May 28, 1987
DISPOSABLE LASER PROTECTIVE DRAPE FOR CO2 LASER
K871068 · KKX
Lifestream Int'L, Inc.
General Hospital · 71d
Cleared May 28, 1987
FLAME PHOTOMETER STANDARD #60081 120 NA/2K
K871182 · JIX
In Vitro Diagnostics, Inc.
Chemistry · 65d
Cleared May 28, 1987
FLAME PHOTOMETER STANDARD #60082 140 NA/5K
K871183 · JIX
In Vitro Diagnostics, Inc.
Chemistry · 65d
Cleared May 28, 1987
FLAME PHOTOMETER STANDARD #60083 160 NA/8K
K871184 · JIX
In Vitro Diagnostics, Inc.
Chemistry · 65d
Cleared May 28, 1987
LITHIUM INTERNAL STANDARD 1 MEQ/L #60085
K871185 · JIS
In Vitro Diagnostics, Inc.
Chemistry · 65d
Cleared May 28, 1987
CESIUM DILUENT 1.5 MMOL CS/L #60087
K871186 · JIS
In Vitro Diagnostics, Inc.
Chemistry · 65d
Cleared May 28, 1987
LITHIUM INTERNAL STANDARD 3000 MEQ/L #60084
K871187 · JIS
In Vitro Diagnostics, Inc.
Chemistry · 65d
Cleared May 28, 1987
LITHIUM INTERNAL STANDARD 1500 MEQ/L #60086
K871188 · JIS
In Vitro Diagnostics, Inc.
Chemistry · 65d