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
144289–144312 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 15, 1986
JOINT MEASUREMENT INDICATOR
K861264 · JDL
Devcom, Inc.
Orthopedic · 11d
Cleared Apr 14, 1986
BOMED-CDM
K853706 · DSB
Bomed Medical Mfr., Ltd.
Cardiovascular · 222d
Cleared Apr 14, 1986
EARLENS
K854311 · ESD
Sound Acoustic Systems, Ltd.
Ear, Nose, Throat · 171d
Cleared Apr 14, 1986
TIGER'S DIGITAL THERMOMETER
K854349 · FLL
Tiger Electronics, Inc.
General Hospital · 167d
Cleared Apr 14, 1986
ULTRASONIC COUPLANT GEL
K854996 · JOP
Johnson & Johnson Professionals, Inc.
Cardiovascular · 123d
Cleared Apr 14, 1986
MX4040 INTRAUTERINE PRESSURE MONITORING KIT
K860101 · KXO
Medex, Inc.
Obstetrics & Gynecology · 94d
Cleared Apr 14, 1986
DU PONT SORVALL CENTRIFUGES (RAPIDSPIN R)
K860747 · JQC
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 46d
Cleared Apr 14, 1986
DISPETTE II
K860899 · JPH
Ulster Scientific, Inc.
Hematology · 35d
Cleared Apr 14, 1986
RESIDENTIAL TANNING UNIT
K861076 · FTC
Sunmaker, Inc.
General & Plastic Surgery · 24d
Cleared Apr 14, 1986
ZIMMER VACUUM MIXING SYSTEM
K861086 · JDZ
Zimmer, Inc.
Orthopedic · 24d
Cleared Apr 14, 1986
HOWMEDICA BIPOLAR PROSTHESIS
K861105 · KWY
Howmedica Corp.
Orthopedic · 21d
Cleared Apr 14, 1986
MASH DERMATOME
K861138 · GFD
Mecron Medical Products, Inc.
General & Plastic Surgery · 19d
Cleared Apr 11, 1986
PRESSURE REGULATOR
K853039 · CAN
Erie Medical
Anesthesiology · 266d
Cleared Apr 11, 1986
TRACHEAL TUBES
K853051 · BTO
Erie Medical
Anesthesiology · 266d
Cleared Apr 11, 1986
ECG-ELECTRODE(SWAROMED)
K853939 · DRX
D. Swarovski & Co.
Cardiovascular · 199d
Cleared Apr 11, 1986
ANESTHESIA VENTILATOR MODEL 100
K854202 · CAD
Rusz Instruments, Inc.
Anesthesiology · 178d
Cleared Apr 11, 1986
MODEL 509A PHYSIOCORDER AMBULATORY RECORDER
K854269 · DSH
Del Mar Avionics
Cardiovascular · 170d
Cleared Apr 11, 1986
FOX FASTIDIOUS TEST PANEL
K854525 · JWY
Beckman Instruments, Inc.
Microbiology · 149d
Cleared Apr 11, 1986
PROPHYLACTIC (CONDOM)
K854622 · HIS
Medelec Intl. Corp.
Obstetrics & Gynecology · 144d
Cleared Apr 11, 1986
LASERSCOPE OMNIPLUS PHOTOSURGICAL SYST/ND:YAG OTOL
K855146 · LMS
Laserscope
Ear, Nose, Throat · 108d
Cleared Apr 11, 1986
MICRO-EIA THEOPHYLLINE TEST KIT MONOCLONAL
K855227 · KLS
Bioclinical Systems, Inc.
Toxicology · 102d
Cleared Apr 11, 1986
TOTAL IGE-IRMA RIA KIT
K860032 · DGC
Diagnostic Products Corp.
Immunology · 95d
Cleared Apr 11, 1986
ANSWER PLUS AT HOME PREGNANCY TEST
K860090 · LCX
Armkel, LLC
Chemistry · 91d
Cleared Apr 11, 1986
ECHOCLONAL HTSH IRMA
K860288 · JLW
Bio-Rad
Immunology · 73d