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
78097–78120 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 24, 2001
MODIFICATION TO FLEXVIEW CLINICAL MONITORING SYSTEM
K011999 · MSX
Data Critical Corp.
Cardiovascular · 27d
Cleared Jul 24, 2001
MODIFICATION TO ALARMVIEW WIRELESS DATA NETWORK SYSTEM
K012005 · MSX
Data Critical Corp.
Cardiovascular · 27d
Cleared Jul 24, 2001
MODIFICATION TO: SIPAP INFANT NASAL CPAP CIRCUIT
K012034 · BZD
Sensor Medics Corp.
Anesthesiology · 25d
Cleared Jul 24, 2001
MODIFICATION TO: ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORK W/SMART ALRAMS
K012171 · MSX
Visicu, Inc.
Cardiovascular · 12d
Cleared Jul 23, 2001
AV 800 VENTILATOR
K010317 · CBK
Penlon , Ltd.
Anesthesiology · 171d
Cleared Jul 23, 2001
PRIMA OXYGEN MONITOR
K010318 · CCL
Penlon , Ltd.
Anesthesiology · 171d
Cleared Jul 23, 2001
ISODAN
K010415 · KLE
Specialites Septodont
Dental · 161d
Cleared Jul 23, 2001
BILATERAL FITTING OF THE BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM.
K011438 · LXB
Entific Medical Systems, Inc.
Ear, Nose, Throat · 74d
Cleared Jul 23, 2001
TOOTH SHADE RESIN MATERIAL
K011453 · EBF
Rite-Dent Manufacturing Corp.
Dental · 73d
Cleared Jul 23, 2001
RESTORE-X
K011520 · EMA
First Scientific Limited
Dental · 67d
Cleared Jul 23, 2001
TRI-FIX SPINAL FIXATION SYSTEM
K011830 · KWP
Endius, Inc.
Orthopedic · 41d
Cleared Jul 23, 2001
FRESENIUS C.A.T.S
K012178 · CAC
Fresenius Hemotechnology, Inc.
Anesthesiology · 11d
Cleared Jul 23, 2001
ADVANTAGE NASAL MASK, SMALL, ADVANTAGE NASAL MASK. REGULAR, MODELS TMS-2520,...
K012207 · BZD
Tiara Medical Systems, Inc.
Anesthesiology · 7d
Cleared Jul 22, 2001
HYSTEROSCOPES
K003802 · HIH
Global Endoscopy, Inc.
Obstetrics & Gynecology · 226d
Cleared Jul 22, 2001
GYNECOLOGICAL LAPAROSCOPES
K003805 · HET
Global Endoscopy, Inc.
Obstetrics & Gynecology · 226d
Cleared Jul 20, 2001
ARTHROSCOPES
K003831 · HRX
Global Endoscopy, Inc.
Orthopedic · 221d
Cleared Jul 20, 2001
BIOCHECK HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT,...
K003851 · DCK
Biocheck, Inc.
Chemistry · 220d
Cleared Jul 20, 2001
MACROPORE OS SPINAL SYSTEM
K010911 · KWQ
Macropore Biosurgery, Inc.
Orthopedic · 116d
Cleared Jul 20, 2001
NORMED EXTREMITY TITANIUM HAND AND SMALL FRAGMENT SYSTEM
K011118 · HRS
Osteomedics
Orthopedic · 99d
Cleared Jul 20, 2001
SYSMEX AUTOMATED COAGULATION ANALYZER / MODEL # CA-1500
K011235 · JPA
Dade Behring, Inc.
Hematology · 88d
Cleared Jul 20, 2001
FLAVORED MALE LATEX CONDOM
K011253 · HIS
Thai Nippon Rubber Industry Co., Ltd.
Obstetrics & Gynecology · 87d
Cleared Jul 20, 2001
NIEN MADE NON-INVASIVE BLOOD PRESSURE MONITOR, MODELS HP-BPM0001
K011310 · DXN
Nien Made Electrnics Corp.
Cardiovascular · 81d
Cleared Jul 20, 2001
STRYKER TITANIUM CROSS-SCREW SYSTEM, MODEL 234-500-1XX
K011319 · JDW
Stryker Endoscopy
Orthopedic · 80d
Cleared Jul 20, 2001
CARDIONAVIGATOR INFORMATION MANAGEMENT SYSTEM
K011345 · DXH
Reynolds Medical , Ltd.
Cardiovascular · 79d