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
81433–81456 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 18, 2000
DIAGNOSTIC ELECTROMYOGRAPHY NEEDLE ELECTRODE, DISPOSABLE HYPODERMIC NEEDLE
K001869 · IKT
Medicotest A/S
Neurology · 90d
Cleared Sep 18, 2000
LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE (MADGIC)
K002255 · CCT
Wolfe Tory Medical, Inc.
Anesthesiology · 55d
Cleared Sep 18, 2000
MODIFICATION TO PANAVIA F
K002322 · EMA
Kuraray America, Inc.
Dental · 49d
Cleared Sep 18, 2000
PELVX GELLHORN VAGINAL PESSARY 603-608
K002329 · HHW
Deschutes Medical Products, Inc.
Obstetrics & Gynecology · 48d
Cleared Sep 18, 2000
QUEST MPS BACK-UP SYSYEM
K002366 · DWF
Quest Medical, Inc.
Cardiovascular · 53d
Cleared Sep 18, 2000
COOK IVF FOLLICLE FLUSHING BUFFER, COOK IVF OOCYTE WASH BUFFER, COOK IVF...
K002385 · MQL
Cook Ob/Gyn
Obstetrics & Gynecology · 45d
Cleared Sep 18, 2000
BIONOSTICS GLUCOSE QUALITY CONTROL SOLUTION FOR USE WITH MEDISENSE BLOOD...
K002540 · JJX
Bionostics, Inc.
Chemistry · 33d
Cleared Sep 18, 2000
6060 MULTI-THERAPY PUMP, MODEL 2M9832
K002679 · FRN
Baxter Healthcare Corp
General Hospital · 21d
Cleared Sep 18, 2000
HL168T
K002750 · DXN
Health & Life Co., Ltd.
Cardiovascular · 13d
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