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
98785–98808 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 28, 1996
GALVA-5-M
K954411 · IPF
Zimmer Elektromedizin GmbH
Physical Medicine · 160d
Cleared Feb 28, 1996
ALKALINE PHOSPHATASE (ALP) PROCEDURE NO. 245
K954840 · CJE
Sigma Diagnostics, Inc.
Chemistry · 131d
Cleared Feb 28, 1996
TRACH MASK MODEL (245, 246)
K955483 · BYF
Hospitak, Inc.
Anesthesiology · 89d
Cleared Feb 28, 1996
LMI BILUMEN IRRIGATION ARTERIAL EMBOLECTOMY CAHTETER
K955499 · MJN
Lucas Medical, Inc.
Cardiovascular · 89d
Cleared Feb 28, 1996
CARDI0METRICS FLOW WIRE XT DOPPLER GUIDE MODEL 1403, 1404
K955551 · DQX
Cardio Metrics, Inc.
Cardiovascular · 85d
Cleared Feb 28, 1996
STERILIZED TRI BLOCK POLYMER GEL SHEET
K955664 · MDA
Silipos, Inc.
General & Plastic Surgery · 77d
Cleared Feb 28, 1996
SPINAL NEEDLE
K960405 · MIA
Promex, Inc.
Anesthesiology · 30d
Cleared Feb 27, 1996
CHEMMATE SPECIAL STAIN LCA-CD45
K936111 · DEH
Biotek Solutions, Inc.
Immunology · 796d
Cleared Feb 27, 1996
PULMOMIST
K952326 · CAF
Global Medical Ent., Inc.
Anesthesiology · 285d
Cleared Feb 27, 1996
ORALSENSOR
K953257 · HCC
Cycura Corp.
Neurology · 230d
Cleared Feb 27, 1996
PREVIEW SURGERY PLANNING SOFTWARE
K953616 · LLZ
Medical Media Systems
Radiology · 208d
Cleared Feb 27, 1996
IDXVIEW
K954071 · LMD
Idx Systems Corp.
Radiology · 181d
Cleared Feb 27, 1996
INTERMEDICS MODEL 430-07 BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEAD
K954719 · DTB
Intermedics, Inc.
Cardiovascular · 137d
Cleared Feb 27, 1996
USSC POLYPROPLENE SUTURE
K954808 · GAW
United States Surgical, A Division of...
General & Plastic Surgery · 131d
Cleared Feb 27, 1996
BREATHE RIGHT NASAL STRIP
K954914 · LWF
Cns, Inc.
Ear, Nose, Throat · 124d
Cleared Feb 27, 1996
SHARPLAN LASERS, INC SILKTOUCH 2 FLASH SCANNER
K955621 · GEX
Sharplan Lasers, Inc.
General & Plastic Surgery · 78d
Cleared Feb 27, 1996
MEDRAD/HITACHI BREAST IMAGING SURFACE COIL
K955626 · MOS
Medrad, Inc.
Radiology · 78d
Cleared Feb 27, 1996
ORTHOPLUG HARD BONE DESIGN
K955631 · LZN
Sunmed, Inc.
Orthopedic · 78d
Cleared Feb 27, 1996
ORTHOPLUG SOFT BONE DESIGN
K955632 · LZN
Sunmed, Inc.
Orthopedic · 78d
Cleared Feb 27, 1996
STAINLESS STEEL SUTURES, FLEXON STEEL SUTURES (STAINLESS)
K955723 · GAQ
Davis & Geck, Inc.
General & Plastic Surgery · 71d
Cleared Feb 27, 1996
USSC NONABSORBABLE SUTURES
K955747 · GAT
United States Surgical, A Division of...
General & Plastic Surgery · 70d
Cleared Feb 27, 1996
WIDEX MODEL SENSO DIGITAL (C16)
K955879 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 61d
Cleared Feb 27, 1996
G.E. STERILE DISPOSABLE RADIOGRAPHIC CONTRAST TRAY
K960146 · IZG
GE Medical Systems
Radiology · 42d
Cleared Feb 27, 1996
G.E. STERILE, PERCUTANEOUS CHOLANGIOGRAPHIC TRAY
K960204 · FRG
GE Medical Systems
General Hospital · 42d