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
139657–139680 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 15, 1987
EMED-F-SYSTEM
K871690 · IKE
Novel GmbH
Physical Medicine · 16d
Cleared May 15, 1987
ANAEROBIC TRANSPORT POUCH (CATALYST-FREE)
K871709 · KZJ
Difco Laboratories, Inc.
Microbiology · 14d
Cleared May 15, 1987
DRIPRIDE DISPOSABLE UNDERPADS
K871725 · KME
Weyerhaeuser Co.
General Hospital · 11d
Cleared May 14, 1987
JOHNSON INTRATRACHEAL OXYGEN CATHETER SET
K870181 · BTO
Cook, Inc.
Anesthesiology · 119d
Cleared May 14, 1987
MEDTRONIC MODEL 4220 AMBULATORY ECG MONITOR
K870652 · DXH
Medtronic Vascular
Cardiovascular · 86d
Cleared May 14, 1987
EFER ARTHROSCOPE
K870654 · HRX
Roseburg SA
Orthopedic · 90d
Cleared May 14, 1987
PENTAMAX 1 MODEL B TABLE SYSTEM
K870707 · IXR
Spectrum X-Ray Corp.
Radiology · 83d
Cleared May 14, 1987
BADGWELL SAMPLING CATHETER
K870858 · CCK
Dryden Corp.
Anesthesiology · 72d
Cleared May 14, 1987
IMMUSTRIP(TM) DSDNA ELISA TEST SYSTEM
K870903 · LRM
Immunomedics, Inc.
Immunology · 70d
Cleared May 14, 1987
CIBA CORNING MAGIC(R) LITE T4 IMMUNOASSAY
K870965 · CDX
Ciba Corning Diagnostics Corp.
Chemistry · 65d
Cleared May 14, 1987
SIMPSON PERIPHERAL ATHEROCATH(TM)
K871011 · LIT
Devices For Vascular Intervention, Inc.
Cardiovascular · 62d
Cleared May 14, 1987
PRECIMAT(R) TRANSFERRIN
K871022 · DDG
Boehringer Mannheim Corp.
Immunology · 59d
Cleared May 14, 1987
PRECIMAT(R) C4
K871023 · DBI
Boehringer Mannheim Corp.
Immunology · 59d
Cleared May 14, 1987
X-CEL X-RAY MODELS ORT90W, ORT90M AND ORT90R
K871116 · IYH
X-Cel X-Ray Corp.
Radiology · 56d
Cleared May 14, 1987
H-H HARRIS NEONATAL NASAL CANNULA SET FOR CPAP
K871351 · BZD
Holter-Hausner Intl.
Anesthesiology · 38d
Cleared May 14, 1987
SIEMENS MAIN FLOW BACTERIA FILTER
K871366 · CAH
Siemens Elema AB
General Hospital · 37d
Cleared May 14, 1987
VISION (TM) HDL CHOLESTEROL
K871461 · LBS
Abbott Laboratories
Chemistry · 30d
Cleared May 14, 1987
TOTAL BILIRUBIN REAGENT 1372,1425,1284,1273,053583
K871530 · CIG
American Research Products Co.
Chemistry · 24d
Cleared May 14, 1987
SMILJANIC BONE REPOSITIONING FORCEPS
K871535 · HTD
Link America, Inc.
General & Plastic Surgery · 24d
Cleared May 14, 1987
HPROLACTIN KIT
K871542 · CFT
Immuchem Corp.
Chemistry · 24d
Cleared May 14, 1987
WESTERN RAGWEED ALLERGEN DISC
K871660 · DHB
Incstar Corp.
Immunology · 16d
Cleared May 13, 1987
HARTFORD TOTAL HIP SYSTEM (TRI-WEDGE)
K870128 · JDI
Richards Medical Co., Inc.
Orthopedic · 121d
Cleared May 13, 1987
THE GONOGEN II TEST KIT FOR NEISSERIA GONORRHOEAE
K871105 · LIC
New Horizons Diagnostics Co.
Microbiology · 55d
Cleared May 13, 1987
ABBOTT A-GENT LD-1 ISOZYME REAGENT
K871240 · JGF
Abbott Laboratories
Chemistry · 47d