Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
160705–160728 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 22, 1982
BN-74 COATED BARDEX ALL SILICONE CATH
K821272 · KOD
C.R. Bard, Inc.
Gastroenterology & Urology · 50d
Cleared Jun 22, 1982
DISPOSABLE IRRIGA/ASPIR. SYSTEM
K821496 · KDH
Innovative Surgical Products, Inc.
Gastroenterology & Urology · 34d
Cleared Jun 22, 1982
MARTIN-LEWIS/PRONG AGAR
K821551 · JTY
Gibco Laboratories Life Technologies,...
Microbiology · 28d
Cleared Jun 22, 1982
VENOSET DUAL-RATE PIGGYBACK W/IVEX &
K821578 · FPA
Abbott Laboratories
General Hospital · 25d
Cleared Jun 22, 1982
SANDHILL DMS
K821588 · KLA
Sandhill
Gastroenterology & Urology · 21d
Cleared Jun 22, 1982
STEAM STERILIZATION EQUIPMENT
K821591 · FLE
Getinge International, Inc.
General Hospital · 21d
Cleared Jun 22, 1982
LOW VOLUME INFUSTION SET
K821624 · FPA
Lifemed of California
General Hospital · 20d
Cleared Jun 22, 1982
GAS CHEX PLASTIC BAG
K821648 · JOJ
Propper Mfg. Co., Inc.
General Hospital · 18d
Cleared Jun 22, 1982
FLEXIFLO-II
K821661 · FRN
Abbott Laboratories
General Hospital · 18d
Cleared Jun 22, 1982
SPINCHEM ACID PHOSPHATASE REAGENT
K821674 · CKB
Smithkline Diagnostics, Inc.
Hematology · 15d
Cleared Jun 22, 1982
CALCITONIN RIA TEST KIT, DLS 1200
K821675 · JKR
Diagnostic Systems Laboratories, Inc.
Chemistry · 14d
Cleared Jun 22, 1982
THE COMMUNICATOR
K821677 · ILQ
Robert Swinney. , Ltd.
Physical Medicine · 14d
Cleared Jun 22, 1982
TITAN GEL HIGH RESOLUTION SERUM PROTEIN
K821688 · JJN
Helena Laboratories
Chemistry · 14d
Cleared Jun 22, 1982
ERIKA HPF 100,200,300 DIALYZER
K821690 · FJI
Erika, Inc.
Gastroenterology & Urology · 14d
Cleared Jun 22, 1982
TDX NETILMICIN
K821698 · LCE
Abbott Laboratories
Chemistry · 14d
Cleared Jun 22, 1982
MGN CONDUCTIVE CONNECTING TUBE, STERILE
K821703 · BYY
Mgn Medical Manufacturing, Inc.
General Hospital · 20d
Cleared Jun 22, 1982
SERIES 10 LIQUID CHROMOTOGRAPH
K821727 · LDM
The Perkin-Elmer Corp.
Toxicology · 11d
Cleared Jun 21, 1982
SURGICAL UTILITY DRAPE
K821313 · FJZ
Megaplast, Inc.
Gastroenterology & Urology · 48d
Cleared Jun 21, 1982
LIGHT WEIGHT ALUMINUM CRUTCHES
K821403 · IPR
Manuco Manufacturing Co., Inc.
Physical Medicine · 41d
Cleared Jun 21, 1982
CERVITRAC TRACTION FRAME & CORD
K821522 · HST
George W. Cottrell
Neurology · 35d
Cleared Jun 21, 1982
ARGYLE VAC-U-CARE 100CC SUCTION RESERV
K821563 · GCY
Sherwood Medical Co.
General & Plastic Surgery · 27d
Cleared Jun 21, 1982
DISPOSABLE HEMOSTATS
K821617 · HRQ
Medcare Products
General & Plastic Surgery · 19d
Cleared Jun 21, 1982
DISPOSABLE NEEDLE HOLDERS
K821618 · FZX
Medcare Products
General & Plastic Surgery · 19d
Cleared Jun 21, 1982
STERILE SURGICAL DRAPES
K821666 · FJZ
Phoenix Glove Co.
Gastroenterology & Urology · 14d