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
92041–92064 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 11, 1997
CEILING MOUNTED LATERAL POSITIONER, MODEL NO. 6896.002
K972442 · JAA
Continental X-Ray Corp.
Radiology · 73d
Cleared Sep 11, 1997
ALTA PLATING SYSTEM
K972479 · HRS
Howmedica Corp.
Orthopedic · 72d
Cleared Sep 11, 1997
BREATH-SO-FRESH TONGUE CLEANER
K972644 · LCN
Intl. Dental Design Specialists, Inc.
Dental · 58d
Cleared Sep 11, 1997
TANDEM-MP OSTASE IMMUNOENZYMETRIC ASSAY
K972666 · CIN
Hybritech, Inc.
Chemistry · 57d
Cleared Sep 10, 1997
COSMED K4
K963373 · BZC
Cosmed Srl
Anesthesiology · 379d
Cleared Sep 10, 1997
MODEL CG-2206 PERSONAL ELECTROCARDIOGRAM (ECG) TRANSMITTER DEVICE (MODIFIED)
K963725 · DXH
Card Guard , Ltd.
Cardiovascular · 415d
Cleared Sep 10, 1997
HTP-1500 LOCALIZED HEAT THERAPY PUMP
K970197 · ILO
Adroit Medical Systems, Inc.
Physical Medicine · 232d
Cleared Sep 10, 1997
IMPULSE HVG
K970847 · IPF
Armstrong Industries, Inc.
Physical Medicine · 187d
Cleared Sep 10, 1997
NARKOMED M ANESTHESIA SYSTEM (M)
K971425 · BSZ
Draeger Medical, Inc.
Anesthesiology · 146d
Cleared Sep 10, 1997
VIRAZYME INFLUENZA ID TEST FOR INFLUENZA TYPES A AND B VIRUSES
K971494 · GNX
Zymetx, Inc.
Microbiology · 139d
Cleared Sep 10, 1997
S3 CYCLIC RPM CONTROL
K971520 · DWB
Stoeckert Instrumente
Cardiovascular · 138d
Cleared Sep 10, 1997
BIOCOR SOFTSHELL VENOUS RESERVOIR (BIOCOR SVR)
K972017 · DTN
Minntech Corp.
Cardiovascular · 103d
Cleared Sep 10, 1997
MULTIDOS, QC6PLUS
K972211 · LHN
Ptw-New York Corp.
Radiology · 90d
Cleared Sep 10, 1997
0.015CC PINPOINT IONIZATION CHAMBER, 0.005 CC PINPOINT IONIZATION CHAMBER
K972212 · LHN
Ptw-New York Corp.
Radiology · 90d
Cleared Sep 10, 1997
BONE PLATE WITH CABLES
K972223 · HRS
Pioneer Surgical Technology
Orthopedic · 89d
Cleared Sep 10, 1997
2D VOG - VIDEO-OCULOGRAPHY
K972243 · GWN
Sensomotoric Instruments, GmbH
Neurology · 86d
Cleared Sep 10, 1997
OSTEO BOS SYSTEM
K972323 · HRS
Osteonics Corp.
Orthopedic · 82d
Cleared Sep 10, 1997
IMPACT AIR 45 HANDPIECE FOR ENDODONTIC USE
K972375 · EFB
Glenwood, LLC
Dental · 77d
Cleared Sep 10, 1997
IMPACT AIR 45 HANDPIECE FOR PERIODONTAL USE
K972376 · EFB
Glenwood, LLC
Dental · 77d
Cleared Sep 10, 1997
PROLENE POLYPROPYLENE MESH HERNIA DEVICE NONABSORBABLE SYNTHETIC SURGICAL MESH
K972412 · FTL
Ethicon, Inc.
General & Plastic Surgery · 76d
Cleared Sep 10, 1997
INNERWEAR, GENTLEMEN'S CHOICE W/NONOXYNOL-9
K972429 · LTZ
Custom Services Intl., Inc.
Obstetrics & Gynecology · 75d
Cleared Sep 10, 1997
EXTRAWEAR, GENTLEMEN'S CHOICE W/NONOXYNOL-9
K972430 · LTZ
Custom Services Intl., Inc.
Obstetrics & Gynecology · 75d
Cleared Sep 10, 1997
AMSINO SUCTION CATHETER
K973199 · BSY
Amsino Intl., Inc.
Anesthesiology · 15d
Cleared Sep 10, 1997
K&W 2-PIECE TAKE-APART INSTRUMENTS(VARIOUS)
K973259 · OCZ
Medical Creative Technologies, Inc.
Gastroenterology & Urology · 12d