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
91609–91632 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Dec 02, 1997
ISO-GARD FILTER ANGLED(18212)/ISO-GARD FILTER STRAIGHT(19212)
K965016 · CAH
Gibeck, Inc.
General Hospital · 351d
Cleared Dec 02, 1997
OHMEDA INFANT RESUSCITATION SYSTEM
K971243 · BTM
Ohmeda Medical
Anesthesiology · 243d
Cleared Dec 02, 1997
FUKUDA DENSHI MODEL FCP-2155 MULTI CHANNEL, INTERPRETIVE ELECTROCARDIOGRAPH
K971440 · LOS
Fukuda Denshi USA, Inc.
Cardiovascular · 228d
Cleared Dec 02, 1997
QUANTA LITE TOXOPLASMA IGG
K971441 · LGD
Inova Diagnostics, Inc.
Microbiology · 228d
Cleared Dec 02, 1997
ACCUDEXA BONE DENSITOMETER
K971735 · KGI
Schick Technologies, Inc.
Radiology · 204d
Cleared Dec 02, 1997
QUICKIE P90 SERIES
K972230 · ITI
Quickie Designs, Inc.
Physical Medicine · 172d
Cleared Dec 02, 1997
FOUNDATION POROUS HIP STEM
K973302 · LPH
Encore Orthopedics, Inc.
Orthopedic · 90d
Cleared Dec 02, 1997
MVM 3.3 MM MICROENDOSCOPE
K973304 · HET
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 90d
Cleared Dec 02, 1997
THERAPAX DXT 300 MODEL HF-300
K973315 · JAD
Pantak, Inc.
Radiology · 90d
Cleared Dec 02, 1997
BACT/ALERT FAN CULTURE BOTTLES
K973325 · MDB
Organon Teknika Corp.
Microbiology · 89d
Cleared Dec 02, 1997
ALCON MULTI-PURPOSE DISINFECTING SOLUTION ID 90746
K973332 · LPN
Alcon Laboratories
Ophthalmic · 89d
Cleared Dec 02, 1997
BONDING BASE
K973353 · DZE
Straumann USA
Dental · 88d
Cleared Dec 02, 1997
AQUAPLAST PALATAL STENT
K973370 · EMA
Wfr/Aquaplast Corp.
Dental · 85d
Cleared Dec 02, 1997
CURVILINEAR SUTURE PLACEMENT SYSTEM
K973415 · GCJ
Laurus Medical Corp.
General & Plastic Surgery · 84d
Cleared Dec 02, 1997
OLICON IMAGING SYSTEMS, INC. ARCHIVE SYSTEMS, NT ARCHIVE, 02ARCHIVE, ARCHIVE
K973463 · LMB
O Tech, Inc.
Radiology · 81d