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
130321–130344 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 23, 1989
DOCUMENT(TM) IRON MAGNESIUM LINEARITY TEST SET
K893141 · JJY
Casco Standards
Chemistry · 59d
Cleared Jun 23, 1989
DOCUMENT(TM) IRON, MAGNES, TRIGLY LINEAR TEST SET
K893142 · JJY
Casco Standards
Chemistry · 59d
Cleared Jun 23, 1989
DEVILBISS MODEL 7351D REVITALIZER CPAP SYSTEM
K893388 · BYE
Devilbiss Health Care, Inc.
Anesthesiology · 53d
Cleared Jun 23, 1989
MI-328, MI-316, MI-388 DIGITAL THERMOMETER
K893391 · FLL
Nam Tai Electronic & Electrical...
General Hospital · 53d
Cleared Jun 23, 1989
AN ALTERNATIVE DIRECT BONDING ORTHO. SYSTEM
K893396 · DYH
American Orthodontics
Dental · 53d
Cleared Jun 23, 1989
SERUMAX (AUTOMATED SERUM CENTRIFUGATION & STATION)
K893400 · JQW
Medical Robotics
Chemistry · 53d
Cleared Jun 23, 1989
COMPACT 2052(TM) DUAL COLLECTION BLOOD RECOVERY
K893402 · CAC
Atrium Medical Corp.
Anesthesiology · 53d
Cleared Jun 23, 1989
URIC ACID REAGENT (PROCEDURE NUMBER 686)
K893416 · KNK
Sigma Chemical Co.
Chemistry · 52d
Cleared Jun 23, 1989
MASTERLAB PFT AND MASTERLAB BODY BOX
K893420 · CCM
Quinton, Inc.
Anesthesiology · 57d
Cleared Jun 23, 1989
CLEARVIEW STREP A
K893422 · GTZ
Unipath , Ltd.
Microbiology · 52d
Cleared Jun 23, 1989
A-PORT IMPLANT VASCULAR ACCESS SYSTEM .6MM/2.29MM
K893460 · LJT
Therex Corp.
General Hospital · 51d
Cleared Jun 23, 1989
ANGIOTEC SPX SPLIT SCREEN DUAL CHANNEL SCAN CONV.
K893476 · JAA
Andros Analyzers, Inc.
Radiology · 50d
Cleared Jun 23, 1989
BYRD EXTRACTOR SET
K893480 · GCC
Medical Engineering and Development...
General & Plastic Surgery · 50d
Cleared Jun 23, 1989
CRONEX QUANTA V RARE EARTH INTENSIFYING SCREEN
K893510 · EAM
E.I. Dupont DE Nemours & Co., Inc.
Radiology · 49d
Cleared Jun 23, 1989
IMLOGIX 1000 IMAGE DISPLAY SYSTEM
K893521 · LLZ
Imlogix A Div. of Microterm
Radiology · 46d
Cleared Jun 23, 1989
FACTOR X DEFICIENT PLASMA
K893523 · GJT
Medical Diagnostic Technologies, Inc.
Hematology · 46d
Cleared Jun 23, 1989
FACTOR IX DEFICIENT PLASMA
K893524 · GJT
Medical Diagnostic Technologies, Inc.
Hematology · 46d
Cleared Jun 23, 1989
FACTOR VIII DEFICIENT PLASMA
K893525 · GJT
Medical Diagnostic Technologies, Inc.
Hematology · 46d
Cleared Jun 23, 1989
FACTOR V DEFICIENT PLASMA
K893533 · GJT
Medical Diagnostic Technologies, Inc.
Hematology · 46d
Cleared Jun 23, 1989
FACTOR XII DEFICIENT PLASMA
K893534 · GJT
Medical Diagnostic Technologies, Inc.
Hematology · 46d
Cleared Jun 23, 1989
FACTOR VII DEFICIENT PLASMA
K893535 · GJT
Medical Diagnostic Technologies, Inc.
Hematology · 46d
Cleared Jun 23, 1989
FACTOR XI DEFICIENT PLASMA
K893536 · GJT
Medical Diagnostic Technologies, Inc.
Hematology · 46d
Cleared Jun 23, 1989
DIASTEMA CLOSING KIT
K893542 · EJF
American Orthodontics
Dental · 46d
Cleared Jun 23, 1989
X-RING SEPARATORS
K893549 · EJF
American Orthodontics
Dental · 46d