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
92161–92184 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 17, 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL600-0016
K972789 · DRT
Alexander Mfg. Co.
Cardiovascular · 84d
Cleared Oct 17, 1997
D72 DIGITAL
K972818 · ESD
Philips Hearing Instruments Co.
Ear, Nose, Throat · 80d
Cleared Oct 17, 1997
N ANTISERUM TO HUMAN TRANSFERRIN
K972840 · DDG
Behring Diagnostics, Inc.
Immunology · 77d
Cleared Oct 17, 1997
STRAIT'MAP OPTION
K973368 · IZI
Ge Medical Systems, Inc.
Radiology · 39d
Cleared Oct 16, 1997
HARMAC BALLOON ANGIOGRAPHIC CATHETER
K962829 · DQO
Harmac Medical Products, Inc.
Cardiovascular · 475d
Cleared Oct 16, 1997
HARMAC BALLOON WEDGE PRESSURE CATHETER
K963335 · DQO
Harmac Medical Products, Inc.
Cardiovascular · 475d
Cleared Oct 16, 1997
CD SPINAL SYSTEM
K964159 · KWP
Sofamor Danek USA,Inc.
Orthopedic · 365d
Cleared Oct 16, 1997
VARI-ANGLE HIP SCREW (VHS) SYSTEM
K964880 · KTT
Walter Abendschein, M.D.
Orthopedic · 315d
Cleared Oct 16, 1997
BRANEMARK SYSTEM ZYGOMATICUS FIXTURE SYSTEM
K970499 · DZE
Nobel Biocare Uas, Inc.
Dental · 248d
Cleared Oct 16, 1997
POWERHEART AECD
K970741 · MKJ
Cardiac Science, Inc.
Cardiovascular · 230d
Cleared Oct 16, 1997
BARD RAPIDFIRE MULTIPLE BAND LIGATOR
K971137 · MND
C.R. Bard, Inc.
Gastroenterology & Urology · 202d
Cleared Oct 16, 1997
REJOYN PENILE SUPPORT SYSTEM
K971576 · LKY
American Medtech
Gastroenterology & Urology · 174d
Cleared Oct 16, 1997
SYNTHES SPINE SMALL STATURE ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM
K971883 · KWQ
Synthes (Usa)
Orthopedic · 147d
Cleared Oct 16, 1997
MOA BONE / M-SPHERE
K972143 · HPZ
Iop, Inc.
Ophthalmic · 132d
Cleared Oct 16, 1997
QUIX RAPID E. COLI O157 STRIP TEST
K972156 · GMZ
Guardian Scientific, Corp.
Microbiology · 129d
Cleared Oct 16, 1997
IMAGEVIEW CORONARY ANGIOGRAPHY DISPLAY AND REVIEW SYSTEM
K972229 · IZI
Heartware, Inc.
Radiology · 125d
Cleared Oct 16, 1997
TBI STAND
K972709 · IYE
Mick Radio-Nuclear Instruments, Inc.
Radiology · 87d
Cleared Oct 16, 1997
DURATION STABILIZED UHMWPE ACETABULAR COMPONENTS
K972792 · JDI
Howmedica Corp.
Orthopedic · 80d
Cleared Oct 16, 1997
SYNTHES COMBINATION CLAMP AND DYNAMIZATION CLIP
K973017 · KTT
Synthes (Usa)
Orthopedic · 64d
Cleared Oct 16, 1997
LEGACY/LEGACY-D TABLE
K973039 · IXR
GE Medical Systems
Radiology · 63d
Cleared Oct 16, 1997
DRTS REMOTE CONTROL DRAPE
K973067 · JAA
Minrad, Inc.
Radiology · 59d
Cleared Oct 16, 1997
VINTAGE HALO
K973247 · EIH
Shofu Dental Corp.
Dental · 48d
Cleared Oct 16, 1997
VERABOND 2V
K973265 · EJH
Aalba Dent, Inc.
Dental · 48d
Cleared Oct 16, 1997
BARD ENDOSCOPIC OVERTUBE (#000307)
K973500 · FED
C.R. Bard, Inc.
Gastroenterology & Urology · 30d