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
98377–98400 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 27, 1996
KODAK CARDIOLOGY DIGITAL ARCHIVE & REVIEW SYSTEM
K960043 · LLZ
Jamieson Film Co.
Radiology · 84d
Cleared Mar 27, 1996
REFLECTION DUAL DIMENSION SHELL
K960094 · MBL
Smith & Nephew Richards, Inc.
Orthopedic · 76d
Cleared Mar 27, 1996
ULTRA III
K960096 · IPF
Excel Tech. , Ltd.
Physical Medicine · 76d
Cleared Mar 27, 1996
KIS MT4
K960111 · DZE
The Implant Center of the Palm Beaches
Dental · 76d
Cleared Mar 27, 1996
DEPUY POROCOAT HPS II HIP PROSTHESIS W/ARTICUL-EZE TAPER
K960172 · LPH
Depuy, Inc.
Orthopedic · 71d
Cleared Mar 27, 1996
SENSITITRE 18 HOUR SUSCEPTIBILITY PLATES
K960235 · JWY
Accumed Intl., Inc.
Microbiology · 70d
Cleared Mar 27, 1996
CERAMIC BLADE ELECTRODE
K960255 · GEI
Utah Medical Products, Inc.
General & Plastic Surgery · 70d
Cleared Mar 27, 1996
STERILE KIRSCHNER WIRES AND STEINMANN PINS
K960385 · HTY
Depuy, Inc.
Orthopedic · 61d
Cleared Mar 27, 1996
ULTRA IV
K960489 · IPF
Excel Tech. , Ltd.
Physical Medicine · 54d
Cleared Mar 27, 1996
OPTEON UNIPOLAR
K960538 · KWL
Exactech, Inc.
Orthopedic · 49d
Cleared Mar 26, 1996
MANAN UNIVERSAL SUMP DRAINAGE CATHETER
K953601 · LJE
Manan Medical Products, Inc.
Gastroenterology & Urology · 237d
Cleared Mar 26, 1996
MANAN GENERAL UTILITY DRAINAGE CATHETER
K953713 · LJE
Manan Medical Products, Inc.
Gastroenterology & Urology · 251d
Cleared Mar 26, 1996
RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH ELONGATED & TREADED CUFF &...
K953945 · DWF
Dlp, Inc.
Cardiovascular · 218d
Cleared Mar 26, 1996
MANAN BILIARY DRAINAGE CATHETER
K954043 · FGE
Manan Medical Products, Inc.
Gastroenterology & Urology · 210d
Cleared Mar 26, 1996
MANAN MANTA CATHETER FIXATION DISK
K954132 · KNY
Manan Medical Products, Inc.
Gastroenterology & Urology · 207d
Cleared Mar 26, 1996
MANAN MALECOT BASKET DRAINAGE CATHETER
K954147 · FEW
Manan Medical Products, Inc.
Gastroenterology & Urology · 203d
Cleared Mar 26, 1996
FOAMSEAL RETROGRADE CARDIOPLEGIA CATHETER
K955818 · DWF
Quest Medical, Inc.
Cardiovascular · 91d
Cleared Mar 26, 1996
STORZ MVS 1011A DISPOSABLE FIBEROPTIC ENDOILLUMINATOR
K960007 · MPA
Storz
Ophthalmic · 84d
Cleared Mar 26, 1996
RMI INTERNAL MAMMARY ARTERY CANNULA
K960098 · DQR
Research Medical, Inc.
Cardiovascular · 75d
Cleared Mar 26, 1996
COMSAT ADULT,PEDIATRIC,INFANT,NEONATAL DISPOSABLE SENSOR AND COMSAT REUSABLE...
K960251 · DQA
Aristo Medical Products, Inc.
Anesthesiology · 68d
Cleared Mar 25, 1996
DANTEC MONOPOLAR LUMEN ELECTRODE (13R18 AND 13R19)
K950314 · GXZ
Dantec Medical, Inc.
Neurology · 424d
Cleared Mar 25, 1996
PERCEPTOR COMPENSATOR MORSE MANIFOLD
K951722 · DRS
Namic
Cardiovascular · 346d
Cleared Mar 25, 1996
PROTEGE ER:YAG SURGICAL LASER SYSTEM AND ACCESSORIES
K951876 · GEX
Xintec Corporation
General & Plastic Surgery · 339d
Cleared Mar 25, 1996
PRODIGY SUPERPULSE ND:YAG SURGICAL LASER SYSTEMS & ACCESSORIES
K951935 · GEX
Xintec Corporation
General & Plastic Surgery · 335d