FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
133105–133128 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 30, 1989
DU PONT ACA METHOTREXATE CALIBRATOR
K884745 · DLJ
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 77d
Cleared Jan 30, 1989
TECHNICON CHEM 1 SYSTEM ACID PHOSPHATASE (TOTAL)
K884747 · CKB
Technicon Instruments Corp.
Chemistry · 77d
Cleared Jan 30, 1989
TECHNICON CHEM 1 SYSTEM ACID PHOS (PROSTATIC)
K884748 · JFH
Technicon Instruments Corp.
Chemistry · 77d
Cleared Jan 30, 1989
VASCULAR ACCESS PORT HUBER POINT INFUSION NEEDLES
K884792 · FMI
Infucare Products, Inc.
General Hospital · 76d
Cleared Jan 30, 1989
KODAK DENTAL BARRIER PAC
K884827 · IWZ
Eastman Kodak Company
Radiology · 73d
Cleared Jan 30, 1989
COAGULATION CONTROL PLASMA (NORMAL & ABNORMAL)
K884854 · GGN
Precision Biologicals, Inc.
Hematology · 73d
Cleared Jan 30, 1989
THROMBOPLASTIN
K884855 · GJS
Precision Biologicals, Inc.
Hematology · 73d
Cleared Jan 30, 1989
APTT REAGENT
K884856 · GFO
Precision Biologicals, Inc.
Hematology · 73d
Cleared Jan 30, 1989
PERMASEAL AND DENTURE SEAL
K884865 · EBI
American Mfg., Inc.
Dental · 69d
Cleared Jan 30, 1989
DIDECO-SHILEY AUTOTRANSFUSION CARDIOTOMY RESERVOIR
K884872 · DTN
Shiley, Inc.
Cardiovascular · 70d
Cleared Jan 30, 1989
CARDIOTOMY RESERVOIR VALVE NO. CRV-30 OR PCRV-25
K884893 · KRI
American Omni Medical, Inc.
Cardiovascular · 69d
Cleared Jan 30, 1989
BIOTROL INORGANIC PHOSPHORUS
K885041 · CEO
Biotrol, USA, Inc.
Chemistry · 56d
Cleared Jan 30, 1989
BIOTROL URINE PROTEINS REAGENT
K885053 · JIR
Biotrol, USA, Inc.
Chemistry · 54d
Cleared Jan 30, 1989
MICRO SURGICAL INSTRUMENT SYSTEM
K885273 · HSZ
Tava Surgical Instruments
Orthopedic · 39d
Cleared Jan 30, 1989
TOTAL BILIRUBIN TEST CATALOG NO. SR1007
K885284 · CIG
Em Diagnostic Systems, Inc.
Chemistry · 38d
Cleared Jan 30, 1989
DIRECT BILIRUBIN TEST CATALOG NO. SR1008
K885285 · CIG
Em Diagnostic Systems, Inc.
Chemistry · 38d
Cleared Jan 30, 1989
VITACOMM MODEL #140/141 ESOPHAGEAL STETHOSCOPE
K885347 · BZT
Vitacomm, Inc.
Anesthesiology · 33d
Cleared Jan 30, 1989
MODEL 6208,6209,6210,6211,6212,6214 (PLI'S)
K890045 · DTB
Medtronic Vascular
Cardiovascular · 25d
Cleared Jan 27, 1989
UB ANALYZER, MODEL UA-1/REAGENT KIT/BILIRUBIN CON.
K871115 · CIG
Labo Science-USA, Inc.
Chemistry · 680d
Cleared Jan 27, 1989
KARLSON OZONE STERILIZER MODEL 100B
K873200 · FLF
Life Enhancement Technologies, LLC
General Hospital · 533d
Cleared Jan 27, 1989
ATYPICAL CHOLINESTERASE
K873496 · DIH
Sclavo, Inc.
Chemistry · 528d
Cleared Jan 27, 1989
CHOLINESTERASE - BUTYRYTHIOCHOLINE SUBSTRATE
K880049 · DIH
Sclavo, Inc.
Chemistry · 387d
Cleared Jan 27, 1989
CHOLINESTERASE - ACETYTHIOCHOLINE SUBSTRATE
K880199 · DIH
Sclavo, Inc.
Chemistry · 380d
Cleared Jan 27, 1989
BECKMAN LIQUID-STAT MAGNESIUM REAGENT & STANDARD
K883967 · JGJ
Beckman Instruments, Inc.
Chemistry · 129d