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
91081–91104 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Dec 04, 1997
UNIFINE PENTIPS
K973899 · FMI
Owen Mumford USA, Inc.
General Hospital · 51d
Cleared Dec 04, 1997
EPIC-FLO
K973976 · EBF
Parkell, Inc.
Dental · 45d
Cleared Dec 03, 1997
STARLIGHT PULSED DIODE ARRAY LASER SYSTEM
K973324 · GEX
Star Medical Technologies, Inc.
General & Plastic Surgery · 90d
Cleared Dec 03, 1997
TWEEZER-TYPE EPILATOR
K973340 · KCX
Mobit, Inc.
General & Plastic Surgery · 89d
Cleared Dec 03, 1997
HEWLETT-PACKARD MODELS M1001B ECG M1002B ECG/RESPIRATION PLUG-IN MODULES
K973437 · DPS
Hewlett-Packard GmbH
Cardiovascular · 84d
Cleared Dec 03, 1997
SENDX 100 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM
K973742 · CGZ
Sendx Medical, Inc.
Chemistry · 63d
Cleared Dec 03, 1997
TRIAGE PANEL FOR DRUGS OF ABUSE, PLUS TRICYCLIC ANTIDEPRESSANTS AND OTHER...
K973784 · DKZ
Biosite Incorporated
Toxicology · 61d
Cleared Dec 03, 1997
S-357 VIDEO IMAGING SYSTEM
K973798 · FET
Sopro
Gastroenterology & Urology · 58d
Cleared Dec 02, 1997
CRITERION, CRITERION I.V., MODIFIED
K952267 · BZE
Nova-Ventrx
Anesthesiology · 932d