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
72385–72408 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 19, 2003
PATHWAY CTS2000 PELVIC FLOOR TRAINING SYSTEM
K023906 · KPI
The Prometheus Group
Gastroenterology & Urology · 89d
Cleared Feb 19, 2003
SPIFE 3000 TITAN GEL IGG IEF KIT, MODEL 3389
K024162 · CFF
Helena Laboratories
Immunology · 64d
Cleared Feb 19, 2003
PRECISION CAPILLARIES FOR MICROMANIPULATION
K024302 · MQH
Brinkmann Instruments, Inc.
Obstetrics & Gynecology · 57d
Cleared Feb 19, 2003
NEXUS INJECTION SITE (NIS), MODEL NIS-1
K024363 · FPA
Nexus Medical, LLC
General Hospital · 50d
Cleared Feb 19, 2003
MEDTRONIC MINIMED SOF-SITE INFUSION SET, MODELS MMT-358S6, MMT-358M6,...
K030137 · FPA
Avail Medical Products, Inc.
General Hospital · 36d
Cleared Feb 19, 2003
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WHITE COLOR
K030148 · LYZ
Shanghai Palomar Mountain Industries,...
General Hospital · 35d
Cleared Feb 19, 2003
POWDER FREE LATEX EXAMINATION GLOVES, STERILE WITH PROTEIN CONTENT LABELING...
K030157 · LYY
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 34d
Cleared Feb 19, 2003
BISCOVER LIQUID POLISH KIT, BISCOVER LIQUID POLISH AND BISCOVER VISCOSITY...
K030354 · EBD
Bisco, Inc.
Dental · 16d
Cleared Feb 14, 2003
EMBOL-X AORTIC FILTERS,ETRA-SMALL,SMALL,MEDIUM,LARGE,EXTRA LARGE,MODELS...
K022071 · DTM
Embol-X, Inc.
Cardiovascular · 233d
Cleared Feb 14, 2003
STEERABLE GUIDEWIRE
K022813 · DQX
Lake Region Mfg., Inc.
Cardiovascular · 172d
Cleared Feb 14, 2003
RELIANT BTL 5000 PULS ELECTRICAL STIMULATION SYSTEM, RELIANT BTL 5000 SONO...
K023050 · IMG
Reliant Technologies, Inc.
Physical Medicine · 154d
Cleared Feb 14, 2003
ATAC PAK CREATININE REAGENT AND ATAC CALIBRATOR
K023407 · CGX
Elan Diagnostics
Chemistry · 127d
Cleared Feb 14, 2003
PLATELETWORKS, MODELS PW-A, PW-C
K023761 · JOZ
Helena Laboratories
Hematology · 98d
Cleared Feb 14, 2003
TAI-CHI AND MASTER ACUPUNCTURE NEEDLES
K023787 · MQX
Lhasa Medical, Inc.
General Hospital · 93d
Cleared Feb 14, 2003
ALBUMIN COBALT BINDING TEST (ACB TEST)
K023824 · NJV
Ischemia Technologies, Inc.
Chemistry · 88d
Cleared Feb 14, 2003
SMARTSTITCH M-CONNECTOR, MODEL OM-8005
K023843 · OCW
Opus Medical, Inc.
Gastroenterology & Urology · 88d
Cleared Feb 14, 2003
MODEL 675GE-64 PERIPHERAL VASCULAR COIL CONSISTING OF MODEL 665GE-64: LOWER...
K023848 · MOS
Igc-Medical Advances, Inc.
Radiology · 87d
Cleared Feb 14, 2003
SAMARITAN AED, MODEL SAM-01
K023854 · MKJ
Heartsine Technologies, Inc.
Cardiovascular · 87d
Cleared Feb 14, 2003
ST. GEORGE TECHNOLOGY, INC PERFECTION PLUS DISPOSABLE PROPHY ANGLE
K023953 · EGS
St. George Technology, Inc.
Dental · 79d
Cleared Feb 14, 2003
CONTAFLEX GM3 49% (ACOFILCON B) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR...
K024045 · LPL
Contamac, Ltd.
Ophthalmic · 70d
Cleared Feb 14, 2003
GUIDANT SYNCRUS INTERNAL CARDIOVERSION SYSTEM
K024071 · NHW
Guidant Corporation, Cardiac Surgery
Cardiovascular · 66d
Cleared Feb 14, 2003
4 SEASONS
K024094 · EBF
Ivoclar Vivadent, Inc.
Dental · 65d
Cleared Feb 14, 2003
SUMMIT MEDICAL LTD CELLTRANS POSTOPERATIVE AUTOTRANSFUSION SET, MODELS...
K024097 · CAC
Summit Medical , Ltd.
Anesthesiology · 64d
Cleared Feb 14, 2003
SURGICAL TITANIUM MESH SYSTEM
K030249 · MQP
Depuyacromed
Orthopedic · 21d