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
92257–92280 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 22, 1997
CAUSSE UNIVERSAL OSSICULAR REPLACEMENT PROSTHESIS (ORP/1)
K963899 · ETA
Exmoor Plastics , Ltd.
Ear, Nose, Throat · 329d
Cleared Aug 22, 1997
DTX-200 BONE DENSITOMETER
K964562 · KGI
Osteometer Meditech A/S
Radiology · 282d
Cleared Aug 22, 1997
HEADLOC CERAMIC HEAD
K970675 · LZO
Ortho Development Corp.
Orthopedic · 179d
Cleared Aug 22, 1997
DRAPE, SURGICAL-LATEX
K970891 · KKX
Protek Medical Products, Inc.
General Hospital · 164d
Cleared Aug 22, 1997
WARMETTE
K971117 · LHC
Olympic Medical Corp.
General Hospital · 148d
Cleared Aug 22, 1997
CRT2000 THERMOGRAPHIC SYSTEM
K971956 · LHQ
Werner Eidam Medizin-Technologie GmbH
Radiology · 87d
Cleared Aug 22, 1997
MEDTRONIC MODEL 3273/3274 RF RECEIVER AND MODEL 3629/3630 SCREENER
K972043 · GZB
Medtronic Vascular
Neurology · 81d
Cleared Aug 22, 1997
IMMULITE 2000 PSA
K972095 · LTJ
Diagnostic Products Corp.
Immunology · 79d
Cleared Aug 22, 1997
MENICON SF-P AND MENICON Z RIGID GAS PERMEABLE CONTACT LENS
K972443 · HQD
Menicon U.S.A., Inc.
Ophthalmic · 53d
Cleared Aug 22, 1997
LIFT MASTER
K972563 · ITI
Mechanical Application Designs, Inc.
Physical Medicine · 44d
Cleared Aug 22, 1997
CHASE BLOOD VESSEL SHUNT
K972665 · DWF
Chase Medical, Inc.
Cardiovascular · 37d
Cleared Aug 22, 1997
ACCURUN 146 CMV IGM POSITIVE CONTROL
K972884 · LKQ
Boston Biomedica, Inc.
Microbiology · 17d
Cleared Aug 21, 1997
ARROWGARD BLUE QUAD-LUMEN CENTRAL VENOUS CATHETER
K962577 · FOZ
Arrow Intl., Inc.
General Hospital · 416d
Cleared Aug 21, 1997
VENOMIDICARD PEDIATRIC VENOUS RESERVOIR WITH INTEGRALCARDIOTOMY...
K964907 · DTN
Sorin Biomedical, Inc.
Cardiovascular · 255d
Cleared Aug 21, 1997
RID-DECUBE II
K965207 · FNM
Skin Care Management, Inc.
General Hospital · 237d
Cleared Aug 21, 1997
T-WALL UNCUFFED TRACHEAL TUBE
K970196 · BTR
Vital Signs, Inc.
Anesthesiology · 212d
Cleared Aug 21, 1997
SHIELDED SURGICAL TROCAR
K971475 · GCJ
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 120d
Cleared Aug 21, 1997
ENDOXANE
K971509 · NWA
Novatech SA
General & Plastic Surgery · 118d
Cleared Aug 21, 1997
SCANNING DEVICE ACCESSORY FOR USE WITH THE CB DIODE/532 ND:YAG LASER
K971903 · GEX
Continuum Biomedical, Inc.
General & Plastic Surgery · 90d
Cleared Aug 21, 1997
TOA
K972061 · LRK
W. Keith Thornton, D.D.S.
Dental · 79d
Cleared Aug 21, 1997
INSIGHT 7000 PHASED ARRAY TORSO COIL
K972340 · MOS
Usa Instruments, Inc.
Radiology · 58d
Cleared Aug 21, 1997
MODEL 50 BIPOLAR COAGULATOR
K972350 · GEI
Boston Surgical Products, Inc.
General & Plastic Surgery · 58d
Cleared Aug 21, 1997
AD-HEAL HYDROGEL DRESSING, VARIOUS SIZES
K972646 · NAE
Ludlow Technical Products
General & Plastic Surgery · 37d
Cleared Aug 21, 1997
AXT 150M MANUAL COLLIMATOR (AXT 150M)
K972966 · IZX
Applied X-Ray Technologies, Inc.
Radiology · 10d