FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
91585–91608 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 05, 1997
SPHINCTEROTOME
K973826 · KNS
Boston Scientific Corp
Gastroenterology & Urology · 59d
Cleared Dec 05, 1997
CARBON FIBER CONFORMAL COUCH TOP
K973842 · IXQ
Medtec, Inc.
Radiology · 58d
Cleared Dec 05, 1997
EL-B2GP1SCR
K973882 · MSV
Theratest Laboratories, Inc.
Immunology · 52d
Cleared Dec 05, 1997
ALANINE AMINOTRANSFERASE-SL ASSAY CATALOGUE NUMBER 318-10, 318-30
K974003 · CKA
Diagnostic Chemicals , Ltd.
Chemistry · 45d
Cleared Dec 05, 1997
ACCUWELL PHENYLALANINE ASSAY
K974047 · JNB
Neometrics, Inc.
Chemistry · 42d
Cleared Dec 04, 1997
VAPOPHENE
K961289 · MED
Germiphene Corp.
General Hospital · 609d
Cleared Dec 04, 1997
POWDER-FREE EXAM GLOVES
K970773 · LYY
Pt. Sarana Indoprotex
General Hospital · 275d
Cleared Dec 04, 1997
PERSONAL INFUSOR
K971362 · MEB
Science Incorporated
General Hospital · 237d
Cleared Dec 04, 1997
RHYTHMSTAT XL
K971650 · DXH
Data Critical Corp.
Cardiovascular · 212d
Cleared Dec 04, 1997
SMC FEMORAL HIP COMPONENT
K971681 · JDI
Signal Medical Corp.
Orthopedic · 212d
Cleared Dec 04, 1997
REACH FEMORAL HIP COMPONENT
K971824 · LPH
Biomet, Inc.
Orthopedic · 202d
Cleared Dec 04, 1997
GOWN POLY REINFORCED LARGE(PRODUCT NO.900-522)/(REORDER NO. 0522)
K971920 · FYA
Customed, Inc.
General Hospital · 195d
Cleared Dec 04, 1997
AUTIMO 2.5-D AND AUTIMO 3-D
K972016 · IXI
C.L. Mcintosh & Assoc., Inc.
Radiology · 188d
Cleared Dec 04, 1997
CARDIOCALL CARDIAC EVENT RECORDER
K972649 · DXH
Reynolds Medical , Ltd.
Cardiovascular · 142d
Cleared Dec 04, 1997
CANDELA GENTLELASE GL DERMATOLOGICAL VASCULAR LESION LASER
K972767 · GEX
Candela Corp.
General & Plastic Surgery · 133d
Cleared Dec 04, 1997
MENTOR SUPER ABSORBENT DRAPE
K973146 · KKX
Mentor Ophthalmics, Inc.
General Hospital · 104d
Cleared Dec 04, 1997
STERLING DIAGNOSTIC IMAGING DIRECT RADIOGRAPHY
K973206 · MQB
Sterling Diagnostic Imaging, Inc.
Radiology · 100d
Cleared Dec 04, 1997
SHARPLAN EPITOUCH ALEXANDRITE LASER SYSTEM (5000)
K973354 · GEX
Sharplan Lasers, Inc.
General & Plastic Surgery · 90d
Cleared Dec 04, 1997
DIGMI-2000 (GSI INTERNAL REFERENCE)/LD2800 (MARKETING NAME)
K973411 · LMA
General Scanning, Inc.
Radiology · 86d
Cleared Dec 04, 1997
MECHANICAL FOLDING WHEEL CHAIR
K973491 · IOR
Heartway Medical Products Co., Ltd.
Physical Medicine · 80d
Cleared Dec 04, 1997
KENDALL CURASORB ZN + MG ALGINATE WOUND DRESSING
K973509 · KMF
Kendall Healthcare Products Co....
General & Plastic Surgery · 79d
Cleared Dec 04, 1997
JACKSON-PRATT HEMADUCT WOUND DRAIN, JACKSON-PRATT GOLD HEMADUCT WOUND DRAIN
K973703 · GBX
Allegiance Healthcare Corp.
General & Plastic Surgery · 69d
Cleared Dec 04, 1997
DENTAL/SURGICAL DRILLS, BURS, TAPS
K973771 · DZE
Implant Innovations, Inc.
Dental · 63d
Cleared Dec 04, 1997
AQUASIL XLV SMART WETTING IMPRESSION MATERIAL
K973782 · ELW
Dentsply Intl.
Dental · 62d