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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
138313–138336 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 16, 1987
AMERICAN BRAIN RETRACTOR COVER
K872951 · GET
American Silk Sutures, Inc.
General & Plastic Surgery · 50d
Cleared Sep 16, 1987
HEARING AID (ALL-IN-THE-EAR)
K872977 · ESD
The Hour Glass
Ear, Nose, Throat · 48d
Cleared Sep 16, 1987
TRANSIGEN EXUDATE CONTROLLED WOUND DRESSING
K872988 · NAD
Smith & Nephew, Inc.
General & Plastic Surgery · 47d
Cleared Sep 16, 1987
HEARING AID (ALL IN THE EAR)
K872995 · ESD
Sound Crafters Hearing Instruments
Ear, Nose, Throat · 47d
Cleared Sep 16, 1987
CONCEPT ARTHROSCOPIC PORTAL ROD
K873030 · HRX
Concept, Inc.
Orthopedic · 43d
Cleared Sep 16, 1987
PRECISION HIP LONG STEM FEMORAL COMPONENT SYSTEM
K873089 · JDG
Howmedica Corp.
Orthopedic · 42d
Cleared Sep 16, 1987
REFLO-CHEX, A CHOLESTEROL REFERENCE CONTROL
K873105 · JJX
Streck Laboratories, Inc.
Chemistry · 40d
Cleared Sep 16, 1987
UNIFAST CK-MB
K873134 · CGS
Sclavo, Inc.
Chemistry · 37d
Cleared Sep 16, 1987
VARUS AND VALGUS LEG HOLDER
K873139 · FWZ
Leonard Medical, Inc.
General & Plastic Surgery · 37d
Cleared Sep 16, 1987
CAULK'S VPS CARTRIDGE SYSTEM
K873153 · EID
Dentsply Intl.
Dental · 36d
Cleared Sep 16, 1987
DAHLBERG MODEL GH BODY AID
K873169 · ESD
Dahlberg Electronics, Inc.
Ear, Nose, Throat · 36d
Cleared Sep 16, 1987
HEARING AID (ALL-IN-THE-EAR)
K873189 · ESD
Sight-N-Sound & Co.
Ear, Nose, Throat · 34d
Cleared Sep 16, 1987
MERIFLUOR(TM)-GIARDIA
K873299 · GWD
Meridian Diagnostics, Inc.
Microbiology · 29d
Cleared Sep 16, 1987
120Z(TENS)
K873484 · GZJ
Oms Medico, Inc.
Neurology · 16d
Cleared Sep 16, 1987
LINK (R) AMERICAN-TYPE BONE STAPLE SYSTEM
K873507 · JDR
Link America, Inc.
Orthopedic · 16d
Cleared Sep 15, 1987
HUNTLEIGH FLOWPRESS AC300 PUMP, SQ301/302/320 GAR.
K871271 · DRM
Huntleigh Technology, Inc.
Cardiovascular · 168d
Cleared Sep 15, 1987
SLEEP APNEA NASAL CPAP SYSTEM
K871693 · BYE
Puritan Bennett Corp.
Anesthesiology · 139d
Cleared Sep 15, 1987
LAKE REGION VARIABLE STIFFNESS GUIDEWIRE (VSGW)
K871882 · DQX
Lake Region Mfg., Inc.
Cardiovascular · 127d
Cleared Sep 15, 1987
MR420 TRANSPORT HUMIDIFIER
K872139 · BTT
Fisher & Paykel Allied Products , Ltd.
Anesthesiology · 105d
Cleared Sep 15, 1987
MODEL 366-29 ADAPTAID(TM) ADAPTER SLEEVE
K872230 · DBT
Intermedics, Inc.
Hematology · 98d
Cleared Sep 15, 1987
COLIN'S MODEL APBM-630 AND QUINTON'S MODEL 470
K872355 · DXN
Colin Medical Instruments Corp.
Cardiovascular · 89d
Cleared Sep 15, 1987
HEMOCOR PLUS HEMOCONCENTRATOR
K872456 · KDI
Minntech Corp.
Gastroenterology & Urology · 84d
Cleared Sep 15, 1987
THERMODILUTION CARDIAC OUTPUT COMPUTER, MOD. COM-2
K872529 · DXG
American Edwards Laboratories
Cardiovascular · 81d
Cleared Sep 15, 1987
TRACH CARE CATHETER
K872621 · BSY
Ballard Medical Products
Anesthesiology · 71d