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
99409–99432 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 17, 1996
KARL STORZ TARGETING UNIT
K955652 · HRX
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 36d
Cleared Jan 16, 1996
POINT-OF-CARE ARTERIAL BLOOD GAS MONITORING SYSTEM
K951094 · CCC
Optical Sensors, Inc.
Anesthesiology · 313d
Cleared Jan 16, 1996
LIFESIGNS RECEIVING CENER 2000 TRANSTELEPHONIC RECEIVER
K951096 · DXH
Instromedix, Inc.
Cardiovascular · 315d
Cleared Jan 16, 1996
PACEART CARDIOVOICE
K952065 · DXH
Paceart, Inc.
Cardiovascular · 259d
Cleared Jan 16, 1996
A-1050 EEG MONITOR
K952347 · OLT
Aspect Medical Systems, Inc.
Neurology · 242d
Cleared Jan 16, 1996
SCIMED ANGIOGRAPHIC KITS
K953265 · DQY
Scimed Life Systems, Inc.
Cardiovascular · 187d
Cleared Jan 16, 1996
BIOTREND OXYGEN SATURATION & HEMATOCRIT SYSTEM
K954501 · DTY
Medtronic Bio-Medicus, Inc.
Cardiovascular · 110d
Cleared Jan 16, 1996
TITANIUM GDLH POSTERIOR SPINAL SYSTEM
K954645 · KWP
Sofamor Danek USA,Inc.
Orthopedic · 98d
Cleared Jan 16, 1996
MICRO-DISPENSER 7000 & MICRODISPENSER 8000
K954722 · EFB
NOUVAG AG
Dental · 95d
Cleared Jan 16, 1996
PROFILE NICKEL TITANIUM ROTARY INSTRUMENTS
K954790 · DZA
Tulsa Dental Products, Ltd.
Dental · 89d
Cleared Jan 11, 1996
IDEIA(TM) CHLAMYDIA BLOCKING REAGENTS, MODIFICATION
K940564 · LJC
Dako Diagnostics , Ltd.
Microbiology · 707d
Cleared Jan 11, 1996
OXYCHECK OXYGEN MONITOR
K951038 · CCL
Oxycheck, Inc.
Anesthesiology · 310d
Cleared Jan 11, 1996
GAMBRO HC 14R HEMOCONCENTRATOR
K951311 · KDI
Cobe Renal Care, Inc.
Gastroenterology & Urology · 295d
Cleared Jan 11, 1996
DIALYSIS ADMINISTRATION KITS
K952572 · KOC
B.Braun Medical, Inc.
Gastroenterology & Urology · 220d
Cleared Jan 11, 1996
TRONOMATE PATIENT CABLE & LEADWIRE SYSTEM
K952659 · DSA
Tronomed, Inc.
Cardiovascular · 213d
Cleared Jan 11, 1996
INFANT FEEDING TUBE
K953008 · FPD
Marquette Medical, Inc.
Gastroenterology & Urology · 197d
Cleared Jan 11, 1996
PEDIATRIC QUIK-COMBO
K953204 · MKJ
Physio-Control Corp.
Cardiovascular · 189d
Cleared Jan 11, 1996
R-MED ABDOMINAL WALL ELEVATOR
K953360 · HET
R-Med, Inc.
Obstetrics & Gynecology · 178d
Cleared Jan 11, 1996
LUMAX (MODIFICATION)
K954093 · FEN
Medamicus, Inc.
Gastroenterology & Urology · 155d
Cleared Jan 11, 1996
PERCUTANEOUS INTRA-AORTIC BALLOON CATHETERS
K954431 · DSP
Boston Scientific Corp
Cardiovascular · 108d
Cleared Jan 11, 1996
MOONSHADES SUNGLASSES
K954659 · HQY
Blublocker Corp.
Ophthalmic · 93d
Cleared Jan 11, 1996
MONOTUBE TUBE-TO-TUBE CLAMP
K954667 · JEC
Howmedica Corp.
Orthopedic · 93d
Cleared Jan 11, 1996
DEROYAL INDUSTRIES INFANT HEEL WARMER
K954716 · MPO
Debusk Knitting Mills, Div. Deroyal...
Physical Medicine · 90d
Cleared Jan 11, 1996
PHACO TIP
K954746 · HQC
U.S. Iol, Inc.
Ophthalmic · 87d