FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
133441–133464 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 28, 1988
KD ACTIVATED PARTIAL THROMBOPLASTIN TIME REAGENT
K884485 · GFO
King Diagnostics, Inc.
Hematology · 64d
Cleared Dec 28, 1988
OC-100 OXIMETER INTERFACE CALIBRATOR
K884891 · DQA
Telediagnostic Systems, Inc.
Anesthesiology · 36d
Cleared Dec 28, 1988
CARDIOCAP(TM) CM-104 MONITOR
K884955 · DXN
Datex Division Instrumentarium Corp.
Cardiovascular · 29d
Cleared Dec 28, 1988
COULTER STKS
K885093 · GKZ
Coulter Electronics, Inc.
Hematology · 19d
Cleared Dec 28, 1988
CELL SCRAPER
K885121 · KJA
Bd Becton Dickinson Vacutainer...
Pathology · 16d
Cleared Dec 28, 1988
FACSMATE SAMPLE HANDLING DEVICE
K885132 · GKL
Bd Becton Dickinson Vacutainer...
Hematology · 16d
Cleared Dec 27, 1988
ECG/RESPIRATION/ARRHYTHMIA MODULE FOR RM-301
K880505 · DSI
Ppg Industries, Inc.
Cardiovascular · 326d
Cleared Dec 27, 1988
NEBULIZER HEATER
K882935 · CAF
Automatic Liquid Packaging, Inc.
Anesthesiology · 167d
Cleared Dec 27, 1988
Q5000 ST/HR SLOPE MODIFICATION
K883468 · DPS
Quinton, Inc.
Cardiovascular · 134d
Cleared Dec 27, 1988
SURGICAL CLAMP INSERTS
K883790 · DXC
Applied Vascular Devices, Inc.
Cardiovascular · 111d
Cleared Dec 27, 1988
SURGICAL SPRING CLIPS
K883909 · DSS
Applied Vascular Devices, Inc.
Cardiovascular · 103d
Cleared Dec 27, 1988
CELL SAVER HAEMOLITE B AUTO. BLOOD RECOVERY SYSTEM
K883934 · CAC
Haemonetics Corp.
Anesthesiology · 103d
Cleared Dec 27, 1988
TRANSLUMINAL ENDARTERECTOMY DEVICE
K884154 · LIF
Thomas J. Fogarty, M.D.
Gastroenterology & Urology · 85d
Cleared Dec 27, 1988
BUCHBINDER MULTIFLEX GUIDEWIRE
K884274 · DQX
Medtronic Vascular
Cardiovascular · 76d
Cleared Dec 27, 1988
LABILE LYSING REAGENT
K884315 · LCP
Helena Laboratories
Hematology · 75d
Cleared Dec 27, 1988
PROPAQ 106(TM)
K884320 · DRT
Protocol Systems, Inc.
Cardiovascular · 75d
Cleared Dec 27, 1988
CYTO-STAT/COULTER CLONE T11-RD1/B1-FITC MONO. ANTI
K884346 · GKZ
Coulter Immunology
Hematology · 74d
Cleared Dec 27, 1988
MODIFIED DISPOSABLE COAXIAL BIPOLAR PEN
K884347 · GXI
Advanced Surgical Products, Inc.
Neurology · 74d
Cleared Dec 27, 1988
MODIFIED SHILEY FEMORAL ARTERIAL CANNULA
K884393 · DWF
Shiley, Inc.
Cardiovascular · 77d
Cleared Dec 27, 1988
PHARMASEAL STERILE WOUND CARE DRESSING
K884397 · FRO
Baxter Healthcare Corp
General & Plastic Surgery · 69d
Cleared Dec 27, 1988
KVM BLOOD CELL COUNTER
K884471 · GKL
Kvm Instruments, Inc.
Hematology · 63d
Cleared Dec 27, 1988
FERRITIN SEROZYME IMMUNOENZYMETRIC ASSAY
K884683 · DBF
Serono-Baker Diagnostics, Inc.
Chemistry · 49d
Cleared Dec 27, 1988
KARMA-RS, KARMA-FS WHEELCHAIRS
K884812 · ITI
Orthofab, Inc.
Physical Medicine · 40d
Cleared Dec 27, 1988
ABBOTT SPECTRUM(R) BICARBONATE REAGENT
K884821 · KHS
Abbott Laboratories
Chemistry · 40d