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
132505–132528 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 30, 1989
PREGNA-CARD(TM) A VISUAL HOME PREGNANCY TEST
K883430 · LCX
Disease Detection International, Inc.
Chemistry · 168d
Cleared Jan 30, 1989
MERIT HI-FLEX(TM)
K883718 · FPK
Merit Medical Systems, Inc.
General Hospital · 152d
Cleared Jan 30, 1989
HUMERAL LOCKING NAIL SYSTEM
K883882 · JDS
Howmedica Corp.
Orthopedic · 139d
Cleared Jan 30, 1989
DRIPRIDE PROVIDE SLIM
K883894 · EYQ
Weyerhaeuser Co.
Gastroenterology & Urology · 138d
Cleared Jan 30, 1989
DRIPRIDE ULTRA INCONTINENT PAD
K883895 · EYQ
Weyerhaeuser Co.
Gastroenterology & Urology · 138d
Cleared Jan 30, 1989
CDI(R) 2000 BLOOD GAS MONITOR
K884228 · CBZ
Cardiovascular Devices, Inc.
Anesthesiology · 115d
Cleared Jan 30, 1989
QUADROJECT(TM)
K884233 · FMF
Ellis Pharmaceutical Consulting, Inc.
General Hospital · 115d
Cleared Jan 30, 1989
MODEL 9550/9500 RESPIRATION/HEART RATE MONITOR
K884637 · BZQ
Aequitron Medical, Inc.
Anesthesiology · 84d
Cleared Jan 30, 1989
BIASOL POWDER CONCENTRATES FOR BICARB. DIALYSIS
K884725 · KPO
Baxter Healthcare Corp
Gastroenterology & Urology · 81d
Cleared Jan 30, 1989
ACA DU PONT METHOTREXATE (MTHO) METHOD
K884744 · LAO
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 77d
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