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
101257–101280 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 25, 1995
GAMMACELL 3000 ELAN
K952291 · MOT
Nordion International, Inc.
Radiology · 101d
Cleared Aug 25, 1995
SMARTSAT PULSE OXIMETRY ANALYZER
K952327 · DQA
Clinical Dynamics Corp.
Anesthesiology · 99d
Cleared Aug 25, 1995
ORIMS DIGITAL ANGIOGRAPHY SYSTEM
K952480 · HKI
Midwest Ophthalmic Instruments, Inc.
Ophthalmic · 87d
Cleared Aug 25, 1995
FLOW-THERME, WISAP #7642
K952508 · HET
Wisap Gesellschaft Fur Wissenschaftl....
Obstetrics & Gynecology · 86d
Cleared Aug 25, 1995
AURAFLEX TPO-AB
K952607 · JNL
Organon Teknika Corp.
Immunology · 86d
Cleared Aug 25, 1995
MAPWIRE J-TIP SENSOR GUIDEWIRE
K952626 · LJS
Navion Biomedical Corp.
General Hospital · 78d
Cleared Aug 25, 1995
CUPRALLOY
K952670 · EJJ
Wykle Research, Inc.
Dental · 74d
Cleared Aug 25, 1995
HAND EXTRACTOR HECTOR
K953109 · HIH
Karl Storz Endoscopy
Obstetrics & Gynecology · 53d
Cleared Aug 25, 1995
PULPDENT TOUCHDOWN
K953217 · DYH
Pulpdent Corp.
Dental · 46d
Cleared Aug 25, 1995
PULPDENT DENTASTIC II
K953272 · EMA
Pulpdent Corp.
Dental · 43d
Cleared Aug 25, 1995
DENTASTIC ONE-STEP
K953301 · EMA
Pulpdent Corp.
Dental · 42d
Cleared Aug 25, 1995
DEGUBOND ULTRA
K953344 · EJT
Degussa AG
Dental · 44d
Cleared Aug 25, 1995
HUMID-VENT 1 PORT/HUMID-VENT 1 PORT ANGLE
K953491 · BYD
Gibeck, Inc.
Anesthesiology · 31d
Cleared Aug 25, 1995
EEE
K953540 · BYD
Edentec Corp.
Anesthesiology · 28d
Cleared Aug 25, 1995
HUMID-VENT 2 LIGHT/HUMID-VENT 2 PORT LIGHT
K953544 · BYD
Gibeck, Inc.
Anesthesiology · 28d
Cleared Aug 25, 1995
WARM N WET HME W/LUER ADAPTER
K953619 · BYD
Hospitak, Inc.
Anesthesiology · 22d
Cleared Aug 25, 1995
WARM N WET HMEF W/LUER ADAPTER
K953620 · BYD
Hospitak, Inc.
Anesthesiology · 22d
Cleared Aug 25, 1995
LIGHTED FLEXGUIDE (MODIFICATION)
K953677 · BSR
Scientific Sales Intl., Inc.
Anesthesiology · 18d
Cleared Aug 25, 1995
LMT BONE ANCHOR
K953764 · JDR
Li Medical Technologies, Inc.
Orthopedic · 14d
Cleared Aug 24, 1995
ASEPTECH PORTABLE RO+ SYSTEM
K924695 · FIP
Dayton Water Systems
Gastroenterology & Urology · 1071d
Cleared Aug 24, 1995
SONICAID MODEL TEAM FECG IUP
K930714 · HEL
Oxford Instruments, Plc.
Obstetrics & Gynecology · 924d
Cleared Aug 24, 1995
CENTRA HEART STATION
K935589 · LOS
Marquette Electronics, Inc.
Cardiovascular · 644d
Cleared Aug 24, 1995
VZV IGG ELISA TEST
K941046 · LFY
Gull Laboratories, Inc.
Microbiology · 535d
Cleared Aug 24, 1995
HUMAN C5 RID KITS
K942326 · DAY
Jay H. Geller
Immunology · 468d