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
79513–79536 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 28, 2001
CARDIOIMMUNE TL CARDIAC MARKER CONTROL LEVELS 1, 2, 3, AND MULTI-PACK
K010111 · JJY
Medical Analysis Systems, Inc.
Chemistry · 47d
Cleared Feb 28, 2001
TETRIC CERAM HB
K010250 · EBF
Ivoclar North America, Inc.
Dental · 33d
Cleared Feb 28, 2001
ZOLL M SERIES
K010257 · MKJ
Zoll Medical Corp
Cardiovascular · 30d
Cleared Feb 28, 2001
CARDIOMEDICS ECP SYSTEM
K010261 · DRN
Cardiomedics, Inc.
Cardiovascular · 30d
Cleared Feb 28, 2001
DUAL LUMEN MIDLINE CATHETER
K010349 · LJS
Catheter Innovations, Inc.
General Hospital · 23d
Cleared Feb 28, 2001
ADVANTAGE SINGLE-USE ELECTROSURGICAL ATTACHMENT-J-HOOK TIP, L-HOOK TIP,...
K010444 · GEI
C.R. Bard, Inc.
General & Plastic Surgery · 14d
Cleared Feb 27, 2001
OLYMPUS ENDOSCOPIC LIGATION DEVICE
K001744 · MND
Olympus America, Inc.
Gastroenterology & Urology · 264d
Cleared Feb 27, 2001
DIAMOND ALOE VERA, STERILE
K002666 · MGQ
Medi-Tech Intl. Corp.
General & Plastic Surgery · 186d
Cleared Feb 27, 2001
PARE ENDOSCOPIC SUTURING SYSTEM
K003102 · OCW
Pare Surgical, Inc.
Gastroenterology & Urology · 146d
Cleared Feb 27, 2001
MEDIVISION IGS SYSTEM
K003699 · HAW
Medivision (U.S.A.), Inc.
Neurology · 88d
Cleared Feb 27, 2001
SMF RESORBABLE MESHES AND SHEETS
K003786 · JEY
Synthes (Usa)
Dental · 81d
Cleared Feb 27, 2001
SENSITITRE SUSCEPTIBILITY PLATES-ADDITIONAL ANTIMICROBICS
K003868 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 75d
Cleared Feb 27, 2001
SIGNA SP 0.5T ROTATING HORIZONTAL BODY COIL
K003946 · MOS
GE Medical Systems
Radiology · 68d
Cleared Feb 27, 2001
ENGPLUS
K010059 · GWN
Western Systems Research, Inc.
Neurology · 50d
Cleared Feb 27, 2001
PALFIQUE ESTELITE LV CLEAR
K010267 · EBF
Tokuyama America, Inc.
Dental · 29d
Cleared Feb 27, 2001
DUO-DENT DENTAL IMPLANT
K010386 · DZE
Duo-Dent Dental Implant Systems, LLC
Dental · 19d
Cleared Feb 27, 2001
MODEL THERMO TEK QUICKCARE
K010502 · FLL
Saat , Ltd.
General Hospital · 6d
Cleared Feb 23, 2001
MAEDA NEW NEEDLE DISPOSABLE
K000581 · MQX
Maeda Toyokichi Shoten
General Hospital · 367d
Cleared Feb 23, 2001
EASE-A-CULT
K002756 · KHE
Diagnostica, Inc.
Hematology · 171d
Cleared Feb 23, 2001
ORTHOPILOT
K003347 · HAW
Kinamed, Inc.
Neurology · 121d
Cleared Feb 23, 2001
FREEDLAND TENSION SYSTEM
K003648 · MBI
Etzem Technologies, Inc.
Orthopedic · 88d
Cleared Feb 23, 2001
TRITON HIP SYSTEM
K003649 · LWJ
Hayes Medical, Inc.
Orthopedic · 88d
Cleared Feb 23, 2001
FADASSI MEDICAL FM-1 NO BLENDER
K003665 · MRO
Fadasis Medical, Inc.
Anesthesiology · 87d
Cleared Feb 23, 2001
PERCUSSIVENEB, MODEL PN-2001
K003684 · NHJ
Vortran Medical Technology 1, Inc.
Anesthesiology · 86d