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
80929–80952 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 18, 2000
IPI HUMIDIFIER CHAMBER
K993282 · BTT
I.P.I. Medical Products
Anesthesiology · 354d
Cleared Sep 18, 2000
POWDER FREE LATEX EXAMINATION PATIENT GLOVES
K994420 · LYY
Purna Bina Sdn Bhd
General Hospital · 264d
Cleared Sep 15, 2000
PRO OSTEON 200R RESORBABLE BONE GRAFT SUBSTITUTE, MODELS 2RG051, 2RG101,...
K000515 · MQV
Interpore Cross Intl.
Orthopedic · 212d
Cleared Sep 15, 2000
GENX CODA AIR PURIFICATION SYSTEM
K001486 · MQG
Intl., Inc.
Obstetrics & Gynecology · 126d
Cleared Sep 15, 2000
ADULT/PEDIATRIC CEREBRAL OXIMETER, MODEL INVOS 5100
K001842 · DQA
Somanetics Corp.
Anesthesiology · 88d
Cleared Sep 15, 2000
K-CENTRUM ANTERIOR SPINAL FIXATION SYSTEM
K002371 · KWQ
Spineology, Inc.
Orthopedic · 50d
Cleared Sep 15, 2000
DS DS I-SERIES
K002553 · KPS
Smv America
Radiology · 29d
Cleared Sep 15, 2000
CORDLESS COMPACT MOBILE X-RAY SYSTEM
K002685 · IZL
Medison Radiology Systems, Inc.
Radiology · 18d
Cleared Sep 15, 2000
UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/30
K002694 · CDQ
Diagnostic Chemicals , Ltd.
Chemistry · 17d
Cleared Sep 15, 2000
NICORE MODEL ESP -1
K980937 · DRN
Nicore Equipment & Leasing, Inc.
Cardiovascular · 918d
Cleared Sep 14, 2000
THROMBELASTOGRAPH COAGULATION ANALYZER TEG-5000 SERIES
K002177 · JPA
Haemoscope Corp.
Hematology · 57d
Cleared Sep 14, 2000
ACCOLADE C FEMORAL COMPONENT
K002320 · LZO
Howmedica Osteonics Corp.
Orthopedic · 45d
Cleared Sep 14, 2000
BIO-LOGIC CEEGRAPH NETLINK
K002570 · GWQ
Bio-Logic Systems Corp.
Neurology · 27d
Cleared Sep 14, 2000
ASPECT MEDICAL SYTEMS EEG ENHANCED BIS SENSOR 186-0106
K002734 · GXY
Aspect Medical Systems, Inc.
Neurology · 13d
Cleared Sep 14, 2000
14 FR TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT WITH BLUE FLEXTIP ARROWG+ARD...
K993933 · MPB
Arrow Intl., Inc.
Gastroenterology & Urology · 301d
Cleared Sep 13, 2000
MIDAS TOUCH NITRILE EXAMINATION GLOVES-POWDERFREE
K000138 · LZA
Industrial Clothings, Ltd.
General Hospital · 239d
Cleared Sep 13, 2000
MIDAS TOUCH BLUE NITRILE EXAMINATION GLOVES-POWDERED
K000139 · LZA
Industrial Clothings, Ltd.
General Hospital · 239d
Cleared Sep 13, 2000
MIDAS TOUCH LATEX EXAMINATION GLOVES-POWDERED
K000141 · LYY
Industrial Clothings, Ltd.
General Hospital · 239d
Cleared Sep 13, 2000
MIDAS TOUCH LATEX EXAMINATION GLOVES-POWDER FREE
K000142 · LYY
Industrial Clothings, Ltd.
General Hospital · 239d
Cleared Sep 13, 2000
MIDAS TOUCH NITRILE EXAMINATION GLOVES-POWDERED
K000143 · LZA
Industrial Clothings, Ltd.
General Hospital · 239d
Cleared Sep 13, 2000
MIDAS TOUCH BLUE NITRILE EXAMINATION GLOVES-POWDER FREE
K000145 · LZA
Industrial Clothings, Ltd.
General Hospital · 239d
Cleared Sep 13, 2000
BESTEX POWDER-FREE LATEX EXAM GLOVES WITH LABELING CLAIM. (50 MICROGRAMS OR...
K002087 · LYY
Qingdao Bestex Rubber & Plastic...
General Hospital · 65d
Cleared Sep 13, 2000
ABL-700 SERIES, MODEL ABL 7XX (VARIOUS MODELS)
K002290 · CHL
Radiometer Medical A/S
Chemistry · 48d
Cleared Sep 13, 2000
MOTOR-DRIVE MANIPULATOR MM-89
K002291 · MQJ
Narishige Co., Ltd.
Obstetrics & Gynecology · 48d