FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
83977–84000 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 29, 1999
HYDRAGEL-MINI ISO-CK KIT, HYDRAGEL ISO-CK KIT, HYDRAGEL 7 IS0-CK KIT,...
K992148 · CGS
Morax
Chemistry · 188d
Cleared Dec 29, 1999
STEALTHSTATION TREATMENT GUIDANCE PLATFORM
K992927 · HAW
Surgical Navigation Technologies, Inc.
Neurology · 120d
Cleared Dec 29, 1999
MODIFICATION TO ISOLA SPINAL SYSTEM
K993030 · KWQ
Depuyacromed
Orthopedic · 113d
Cleared Dec 29, 1999
OSCAR NET/CD, MODEL M1.82 600 . O/A/B/C
K993283 · LLZ
Arnold & Richter Cine Technik
Radiology · 90d
Cleared Dec 29, 1999
SULZER CARBOMEDICS CARDIOFIX PERICARDIUM
K993288 · DXZ
Sulzer Carbomedics, Inc.
Cardiovascular · 89d
Cleared Dec 29, 1999
INTEGRATED DIGITAL MEDICAL RECORD (IDMR)
K993338 · LLZ
Ibm Israel , Ltd.
Radiology · 85d
Cleared Dec 29, 1999
LATEX SURGICAL GLOVES, PRE-POWDERED
K993450 · KGO
Fitco Dipped Products Pvt., Ltd.
General Hospital · 78d
Cleared Dec 29, 1999
POWDER FREE LATEX EXAMINATION GLOVES, POLYMER COATED WITH PROTEIN CONTENT...
K993529 · LYY
Biografik (Malaysia) Sdn Bhd
General Hospital · 72d
Cleared Dec 29, 1999
ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL V46
K993542 · DXN
Rossmax International , Ltd.
Cardiovascular · 71d
Cleared Dec 29, 1999
POWDER FREE LATEX STERILE SURGICAL GLOVES
K993562 · KGO
Tg Medical Sdn. Bhd.
General Hospital · 69d
Cleared Dec 29, 1999
RESOLVE QUICKANCHOR
K993575 · DZL
Mitek Products
Dental · 69d
Cleared Dec 29, 1999
HEALTH-PLUS, SANITEX, RELIANCE, BLUE PRE-POWDERED LATEX EXAMINATION GLOVES,...
K993621 · LYY
Pamitex Industries Sdn Bhd
General Hospital · 64d
Cleared Dec 29, 1999
INVIGRA
K993693 · HIS
Indus Medicare , Ltd.
Obstetrics & Gynecology · 57d
Cleared Dec 29, 1999
MODUS SAGITTAL SPLIT PLATE
K993862 · JEY
The Straumann Co.
Dental · 44d
Cleared Dec 29, 1999
DISENTRONIC PENFINE INJECTION PEN NEEDLE
K994197 · FMI
Disetronic Medical Systems
General Hospital · 16d
Cleared Dec 28, 1999
CADENCE DOPPLER ULTRASOUND SYSTEM
K991441 · KNG
Medasonics, Inc.
Radiology · 246d
Cleared Dec 28, 1999
A-MED VASCULAR CANNULA, MODELS V24-10-08, V24-10-16, V24-10-32, V24-21-08,...
K991541 · DWF
A-Med Systems, Inc.
Cardiovascular · 239d
Cleared Dec 28, 1999
PASCAL MEDICAL AB MENIETT 20
K991562 · ETY
Pascal Medical AB
Ear, Nose, Throat · 238d
Cleared Dec 28, 1999
BLADEWORKS DISPOSABLE ALK TUBING
K993591 · KYG
Blade Works, Inc.
Ophthalmic · 67d
Cleared Dec 28, 1999
NEXSYSTEM AMBULATORY PATIENT MONITOR MODEL NEX 100
K993643 · MWJ
Nexan Telemed , Ltd.
Cardiovascular · 61d
Cleared Dec 28, 1999
URETERAL ACCESS SHEATH SET - NEW MODELS
K993650 · FED
Applied Medical Resources
Gastroenterology & Urology · 60d
Cleared Dec 28, 1999
CARDIOVASCULAR MEASUREMENT SYSTEM - VIEW
K993761 · LLZ
Medis Medical Imaging Systems BV
Radiology · 50d
Cleared Dec 27, 1999
MTM BIOSCANNER K TEST STRIPS, CAT # BSA610
K983860 · JMK
Polymer Technology Systems, Inc.
Chemistry · 420d
Cleared Dec 27, 1999
K-CENTRUM ANTERIOR SPINAL FIXATION SYSTEM
K990959 · KWQ
Spineology, Inc.
Orthopedic · 280d