FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
121753–121776 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 17, 1991
QM300 CONTROL G PACK
K910887 · GTQ
Kallestad Diag, A Div. of Erbamont, Inc.
Microbiology · 105d
Cleared Jun 17, 1991
NEXUS(TM) FEMORAL HIP STEM
K911052 · JDI
Dow Corning Wright
Orthopedic · 101d
Cleared Jun 17, 1991
MULTISPECT 3 TRIPLE DETECTOR CAMERA SYSTEM
K911078 · KPS
Siemens Gammasonics, Inc.
Radiology · 98d
Cleared Jun 17, 1991
SI-1200 / ILUS
K911200 · IYO
Siemens Ultrasound, Inc.
Radiology · 90d
Cleared Jun 17, 1991
ARTHROSCOPY INSTRUMENT CANNULA
K911205 · HRX
Davol, Inc.
Orthopedic · 90d
Cleared Jun 17, 1991
SHIMADZU X-RAY HIGH-VOLTAGE GENERATOR XUD150B
K911280 · IZO
Shimadzu Medical Systems
Radiology · 84d
Cleared Jun 17, 1991
HSV IN SITU DNA PROBE HYBRIDIZATION TEST KIT
K911345 · GQN
Diagnostic Hybrids, Inc.
Microbiology · 82d
Cleared Jun 17, 1991
COULTER(R) MH010
K911385 · GKZ
Coulter Electronics, Inc.
Hematology · 81d
Cleared Jun 17, 1991
NON-MYDRIATIC RETINAL CAMERA, CR-45UAF
K911439 · HKI
Canon USA, Inc.
Ophthalmic · 76d
Cleared Jun 17, 1991
MAGNA SURGEONS GOWNS
K911508 · FYA
Dms Miami, Inc.
General Hospital · 75d
Cleared Jun 17, 1991
MAGNA OBSTETRICAL PACKS
K911509 · KKX
Dms Miami, Inc.
General Hospital · 75d
Cleared Jun 17, 1991
MAGNA SURGICAL PACKS
K911510 · KKX
Dms Miami, Inc.
General Hospital · 75d
Cleared Jun 17, 1991
INTRASITE HYDROCOLLOID WOUND DRESSING
K911660 · MGP
Smith & Nephew United, Inc.
General & Plastic Surgery · 66d
Cleared Jun 17, 1991
3M LUTING CEMENT, PASTE A AND B
K911842 · EMA
3M Company
Dental · 53d
Cleared Jun 17, 1991
PF-400,GF-300,IF-200,PG400,PG400C,AND ED-480
K912112 · LQJ
Tomey Corporation USA
Ophthalmic · 35d
Cleared Jun 17, 1991
QUILTONE MODEL 48 PP-AGC-I-D-BEHIND THE EAR
K912153 · ESD
Qualitone
Ear, Nose, Throat · 33d
Cleared Jun 17, 1991
QUALITONE MODEL 48 C-WR-BEHIND THE EAR
K912154 · ESD
Qualitone
Ear, Nose, Throat · 33d
Cleared Jun 17, 1991
MODULE: NOVA NUCLEUS TMG MODULE FLUID PACK
K912321 · JGJ
Nova Biomedical Corp.
Chemistry · 24d
Cleared Jun 17, 1991
PDT CARRYALL TRANSMITTER, VARIOUS MODELS
K912379 · DXH
Cardiac Pacemakers, Inc.
Cardiovascular · 19d
Cleared Jun 14, 1991
CW DOPPLER/4.5 MHZ
K903984 · ITX
Diasonics, Inc.
Radiology · 289d
Cleared Jun 14, 1991
LIMA COLLARED CL STEM
K910836 · JDI
Lima Intl. Corp.
Orthopedic · 107d
Cleared Jun 14, 1991
B-D SAFETY-LOK(TM) I.V. NEEDLES
K911136 · FPA
Bd Becton Dickinson Vacutainer...
General Hospital · 92d
Cleared Jun 14, 1991
HAND CARRIED STRETCHER
K911765 · FPP
L.E. Phillips Career Development...
General Hospital · 56d
Cleared Jun 13, 1991
TXP TRANSPORTER FAMILY AND RELATED ACCESSORIES
K905234 · CBK
Percussionaire Corp.
Anesthesiology · 218d