FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
82873–82896 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 14, 2000
PROFEEL POWDER FREE NITRILE SURGICAL GLOVE, STERILE
K000971 · KGO
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 18d
Cleared Apr 14, 2000
AGILITY STEERABLE GUIDEWIRE
K001033 · DQX
Cordis Neurovascular, Inc.
Cardiovascular · 14d
Cleared Apr 14, 2000
MODIFICATION TO EBI SPINELINK SYSTEM
K001037 · MNI
Ebi, L.P.
Orthopedic · 14d
Cleared Apr 14, 2000
AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS
K991519 · FIP
Ameriwater
Gastroenterology & Urology · 350d
Cleared Apr 14, 2000
SONADA ULTRASOUND SYSTEM
K993092 · OXO
Sonovision Corp.
Radiology · 211d
Cleared Apr 14, 2000
CRYSTAL CUSTOM TINTED SOFT CONTACT LENS
K993489 · LPL
Crystal Reflections, Int., Inc.
Ophthalmic · 182d
Cleared Apr 14, 2000
HAIDER-UCR SPINAL SYSTEM
K993503 · MNH
International Advanced Medical...
Orthopedic · 182d
Cleared Apr 14, 2000
TENAX WHITE POST
K993545 · ELR
Coltene/Whaledent, Inc.
Dental · 178d
Cleared Apr 14, 2000
APPRAISE-CARDIO SAMPLE COLLECTION KIT
K993787 · JKA
Osborn Group, Inc.
Chemistry · 157d
Cleared Apr 13, 2000
ACUCAM CONCEPT IV, MODELS A1222B, A1223B, A1221B, A1121B, A1222C, A10402,...
K000112 · EIA
Dentsply Intl.
Dental · 90d
Cleared Apr 13, 2000
AVID-NIT CERVICAL REGIONAL ANESTHESIA NEEDLE
K000117 · HEE
Avid Medical, Inc.
Obstetrics & Gynecology · 90d
Cleared Apr 13, 2000
CTC DVT-1 CALF GARMENT, MODEL DVT-1
K000147 · JOW
Compression Therapy Concepts, Inc.
Cardiovascular · 86d
Cleared Apr 13, 2000
CS/3 CRITICAL CARE MONITOR WITH S-ICU99(A)
K000168 · MHX
Datex-Ohmeda
Cardiovascular · 84d
Cleared Apr 13, 2000
CORTEK MINI LAPAROSCOPE
K000199 · HET
Cortek Endoscopy, Inc.
Obstetrics & Gynecology · 83d
Cleared Apr 13, 2000
PALS NEONATAL PEDIATRIC ECG ELECTRODE, MODELS PN100, PN200
K000206 · DRX
Axelgaard Mfg. Co., Ltd.
Cardiovascular · 83d
Cleared Apr 13, 2000
HARDYDISK, CEPHALOTHIN 30MCG
K000526 · JTN
Hardy Diagnostics
Microbiology · 57d
Cleared Apr 13, 2000
BLUE MAX BALLOON DILATATION CATHETER, MAXFORCE BALLOON CATHETER, XXL BALLOON...
K000570 · LIT
Boston Scientific Corp
Cardiovascular · 51d
Cleared Apr 13, 2000
DISPOSABLE INJECTOR OR DISPOSABLE SCLEROTHERAPY NEEDLE
K000646 · FBK
Enteric Medical Technologies
Gastroenterology & Urology · 48d
Cleared Apr 13, 2000
RANDOX PREALBUMIN
K000661 · JZJ
Randox Laboratories, Ltd.
Immunology · 45d
Cleared Apr 13, 2000
QUALITROL LIPID CONTROL, LEVELS 1 AND 2
K000810 · JJY
Consolidated Technologies of Wisconsin
Chemistry · 31d
Cleared Apr 13, 2000
PERCUTANEOUS INTRODUCER, MODEL 10383-XXX
K000824 · DYB
Medamicus, Inc.
Cardiovascular · 30d
Cleared Apr 13, 2000
GATIFLOXACIN, 5 UG, BBL SENSI-DISC
K000829 · JTN
Bd Becton Dickinson Vacutainer...
Microbiology · 30d
Cleared Apr 13, 2000
TFX MEDICAL STYLET CATHETER
K992664 · DRB
Tfx Medical Group
Cardiovascular · 248d
Cleared Apr 13, 2000
LEMAITRE OCCLUSION CATHETER
K992942 · MJN
Vascutech, Inc.
Cardiovascular · 226d