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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
106417–106440 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 21, 1994
URESIL DILATOR
K942191 · DYB
Uresil Corp.
Cardiovascular · 140d
Cleared Sep 21, 1994
FORCE GSU SYSTEM MODEL NO. GSU-20 AND GSU-22
K942579 · GEI
Valleylab, Inc.
General & Plastic Surgery · 113d
Cleared Sep 21, 1994
MAGNETIC RESONANCE ANGIOGRAPHY CAPABILITY/OE 1.5 S1
K942776 · LNH
Otsuka Electronics USA, Inc.
Radiology · 100d
Cleared Sep 21, 1994
ROYAL SHIELD RUBBER DAMS
K942992 · EIE
Elastomade Accessories Sdn Bhd
Dental · 93d
Cleared Sep 21, 1994
PRESTERILIZED ENDODONTIC FILES
K943584 · EKJ
Dentsply Intl.
Dental · 61d
Cleared Sep 21, 1994
NIL
K943613 · HOI
Sing Wah International Enterprises ,...
Ophthalmic · 56d
Cleared Sep 21, 1994
KSEA CONTINOUS FLOW CYSTOSCOPE
K943668 · FBO
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 55d
Cleared Sep 21, 1994
RESOUND PERSONAL HEARING SYSTEM
K943788 · ESD
Resound Corp.
Ear, Nose, Throat · 49d
Cleared Sep 21, 1994
MIRACLE EAR CONFIDANTE
K943825 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 47d
Cleared Sep 21, 1994
XLT, REA COMFORT, SPIREA, ZOOM
K943936 · IOR
Electric Mobility Corp.
Physical Medicine · 40d
Cleared Sep 21, 1994
UROLOGICAL GUIDWIRE
K944135 · KNY
Applied Medical Resources
Gastroenterology & Urology · 28d
Cleared Sep 21, 1994
KENDALL MODU-VAC CLOSED SUCTION SYSTEM
K944251 · BSY
Kendall Healthcare Products Co....
Anesthesiology · 21d
Cleared Sep 21, 1994
LIONHEART 3 MULTI-PARAMETER SIMULATOR
K944257 · DRT
Bio-Tek Instruments, Inc.
Cardiovascular · 21d
Cleared Sep 20, 1994
ORTHOSORB(TM) ABSORBABLE CEMENT RESTRICTOR
K932595 · LZN
Johnson & Johnson Orthopaedics, Inc.
Orthopedic · 480d
Cleared Sep 20, 1994
PROSPECT MICROPLATE ASSAY
K934493 · LLH
Alexon, Inc.
Microbiology · 370d
Cleared Sep 20, 1994
IMMUNOCARD MYCOPLASMA
K934550 · LJZ
Meridian Diagnostics, Inc.
Microbiology · 363d
Cleared Sep 20, 1994
BINAX LEGIONELLA URINARY ANTIGEN EIA
K934965 · MJH
Binax, Inc.
Microbiology · 340d
Cleared Sep 20, 1994
CHLAMYDIA MICROPLATE EIA, CHLAMYDIA MICROPLAE EIA BLOCKING ASSAY
K935393 · LJC
Bio-Rad Laboratories, Inc.
Microbiology · 316d
Cleared Sep 20, 1994
ADD LINE DEVICES(PARTS) ELECTRIC HANDPIECE SYSTEMS
K935443 · DZH
Osada Electric Co., Ltd.
Dental · 312d
Cleared Sep 20, 1994
WALLSTENT ESOPHAGEAL PROSTHESIS
K940395 · ESW
Boston Scientific Scimed, Inc.
Gastroenterology & Urology · 236d
Cleared Sep 20, 1994
ELIAS CARDIOLIPIN ANTIBODIES
K940403 · MID
Elias U.S.A., Inc.
Immunology · 236d
Cleared Sep 20, 1994
MEDTRONIC HEMOTEC ACT II AUTOMATED COAGULATION TIMER
K940426 · GKN
Medtronic Hemotec, Inc.
Hematology · 232d
Cleared Sep 20, 1994
THE KARL STORZ UROMAT(TM)
K940983 · LJH
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 203d
Cleared Sep 20, 1994
INTEGRITY TOTAL HIP SYSTEM, NON-POROUS
K941486 · JDI
Kirschner Medical Corp.
Orthopedic · 176d