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
135601–135624 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 16, 1988
AT EASE STRESS PAD
K880454 · EYQ
Hospital Specialty Co.
Gastroenterology & Urology · 135d
Cleared Jun 16, 1988
B. CAT CONFIRM
K880694 · JTO
Scott Laboratories, Inc.
Microbiology · 115d
Cleared Jun 16, 1988
OMRON DIGITAL BLOOD PRESSURE MONITOR HEM-701C
K881269 · DXN
Omron Electronics, Inc.
Cardiovascular · 84d
Cleared Jun 16, 1988
SHERIDAN ELECTROSURGERY PROTECTION FILTER
K881293 · BZT
Sheridan Catheter Corp.
Anesthesiology · 80d
Cleared Jun 16, 1988
BLOOD/SOLUTION SET W/PRESSURE PUMP
K881321 · FPA
Baxter Healthcare Corp
General Hospital · 79d
Cleared Jun 16, 1988
SL02 OXYGEN ANALYZER
K881472 · CCL
Salter Labs
Anesthesiology · 70d
Cleared Jun 16, 1988
SL01 OXYGEN ANALYZER
K881473 · CCL
Salter Labs
Anesthesiology · 70d
Cleared Jun 16, 1988
VEOLAR VENTILATOR
K881482 · CBK
Hamilton Medical, Inc.
Anesthesiology · 69d
Cleared Jun 16, 1988
PRISTINE SPECIMEN TUBE AND INTRODUCER SYSTEM
K881514 · BSK
Hall Laboratories, Inc.
Anesthesiology · 66d
Cleared Jun 16, 1988
UROLOGICAL CATHETER
K881646 · KOD
Coeur Laboratories, Inc.
Gastroenterology & Urology · 62d
Cleared Jun 16, 1988
HUMID-VENT 2 S FLEX
K881656 · BYD
Gibeck Respiration
Anesthesiology · 62d
Cleared Jun 16, 1988
BIOTROL CREATININE H.P. REAGENT
K881856 · CGX
Biotrol, USA, Inc.
Chemistry · 44d
Cleared Jun 16, 1988
SPARE MS 700 TENS ELECTRODE
K881871 · GXY
Lectec Corp.
Neurology · 44d
Cleared Jun 16, 1988
TENS ELECTRODE MODEL 238P
K881872 · GXY
Lectec Corp.
Neurology · 44d
Cleared Jun 16, 1988
VITEK YEAST BIOCHEMICAL CARD
K881925 · JXB
Vitek Systems, Inc.
Microbiology · 38d
Cleared Jun 16, 1988
SUCTION RETRACTORS
K882074 · GAD
Karlin Technology, Inc.
General & Plastic Surgery · 30d
Cleared Jun 16, 1988
SELF-RETAINING SOFT TISSUE RETRACTOR
K882075 · GAD
Karlin Technology, Inc.
General & Plastic Surgery · 30d
Cleared Jun 16, 1988
SPINAL SURGERY FRAME
K882078 · FWZ
Karlin Technology, Inc.
General & Plastic Surgery · 30d
Cleared Jun 16, 1988
RESUSCITATION BAG CONTROLLER (RBC)
K882278 · BTM
Physician Engineered Products, Inc.
Anesthesiology · 15d
Cleared Jun 16, 1988
KODAK EKTASCAN LASER PRINTER ADAPTER, MODEL M6/M8
K882320 · IXW
Eastman Kodak Company
Radiology · 10d
Cleared Jun 16, 1988
DISPOSABLE SYRINGE
K882335 · FMF
Baxter Healthcare Corp
General Hospital · 10d
Cleared Jun 16, 1988
MICROSCOPE SLIDES PRECOATED W/HISTOGRIP & POLY-LY
K882357 · KEW
Stat Path
Pathology · 9d
Cleared Jun 15, 1988
MONITRON SYSTEM
K874148 · DRT
American Health Products, Inc.
Cardiovascular · 246d
Cleared Jun 15, 1988
CIBA CORNING MODEL 280 PH/BLOOD GAS SYSTEM
K880353 · GKR
Ciba Corning Diagnostics Corp.
Chemistry · 141d