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
88777–88800 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 14, 1998
SCOUT 3.2/45 MHZ CORONARY IMAGING CATHETER, SCOUT 3.2/45 MHZ CORONARY IMAGING...
K974457 · IYO
Hewlett-Packard Co.
Radiology · 231d
Cleared Jul 14, 1998
SOFTRANS PLUS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS PLUS...
K974730 · KXO
Graphic Controls Corp.
Obstetrics & Gynecology · 208d
Cleared Jul 14, 1998
AUTO-INJECTOR, SURE-INJECT 2000
K981266 · KZH
Mighty Mo, Corp.
General Hospital · 98d
Cleared Jul 14, 1998
PAR-ONE
K981391 · LIO
Remel, Inc.
Microbiology · 88d
Cleared Jul 14, 1998
0-20 CM H20 PEEP VALVE
K981415 · BYE
Cheen Houng Ent. Co. , Ltd.
Anesthesiology · 85d
Cleared Jul 14, 1998
MEMBRANE TACK
K981459 · DZL
Biomet, Inc.
Dental · 82d
Cleared Jul 14, 1998
XR-910
K981466 · IZL
Imaging Sciences Intl., Inc.
Radiology · 82d
Cleared Jul 14, 1998
OPART (MRT-600) VERSIONS 2 SOFTWARE UPGRADE
K981475 · LNH
Toshiba America Mri, Inc.
Radiology · 81d
Cleared Jul 14, 1998
CARESIDE HDL-CHOLESTEROL
K981899 · LBS
Exigent Diagnostics, Inc.
Chemistry · 43d
Cleared Jul 14, 1998
FLUOROSPOT COMPACT
K982028 · JAA
Siemens Medical Solutions USA, Inc.
Radiology · 35d
Cleared Jul 14, 1998
BIOPSY M
K982049 · IZH
Sitco, Inc.
Radiology · 33d
Cleared Jul 14, 1998
CAAS II LVA BIPLANE OPTION
K982203 · IZI
Pie Medical Equipment B.V.
Radiology · 22d
Cleared Jul 14, 1998
ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
K982250 · CEC
Beckman Instruments, Inc.
Chemistry · 18d
Cleared Jul 13, 1998
HOWMEDICA MODULAR REPLACEMENT SYSTEM - DISTAL FEMORAL/PROXIMAL TIBIAL SEGMENTS
K972401 · KRO
Howmedica Corp.
Orthopedic · 382d
Cleared Jul 13, 1998
ELECTRONIC MUSCLE STIMULATOR - MICROSTIM J-1304D
K980040 · IPF
Nisha Communication Industries
Physical Medicine · 189d
Cleared Jul 13, 1998
LYSONIX SUCTION LIPOPLASTY SYSTEM
K980771 · QPB
Lysonix, Inc.
General & Plastic Surgery · 136d
Cleared Jul 13, 1998
HERMES OPERATING ROOM CONTROL CENTER WITH THE WOM 20L INSUFFLATOR
K980787 · GCJ
Computer Motion, Inc.
General & Plastic Surgery · 133d
Cleared Jul 13, 1998
CANDELA GENTLELASE GL DERMATOLOGICAL LASER
K981351 · GEX
Candela Corp.
General & Plastic Surgery · 90d
Cleared Jul 13, 1998
VPC-94 ULTRA HIGH ENERGY COLLIMATERS MODEL NUMBERS 480-685-9402
K981352 · KPS
Ge Medical Systems F.I. Haifa
Radiology · 90d
Cleared Jul 13, 1998
ARTOSCAN S
K981358 · LHN
Biosound Esaote, Inc.
Radiology · 90d
Cleared Jul 13, 1998
POWERSTAR BIPOLAR SCISSORS
K981361 · GEI
Ethicon, Inc.
General & Plastic Surgery · 90d
Cleared Jul 13, 1998
DEPUY GLOBAL SHOULDER GLENOID
K981487 · KWS
DePuy Orthopaedics, Inc.
Orthopedic · 77d
Cleared Jul 13, 1998
SUTURE PLACEMENT DEVICE AND ACCESSORIES
K981531 · GCJ
Lsi Solutions
General & Plastic Surgery · 75d
Cleared Jul 13, 1998
SURGILON, DERMALON, & OPHTHALON
K981582 · GAR
Davis & Geck, Inc.
General & Plastic Surgery · 70d