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
132841–132864 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 29, 1988
BEHRING POLAROID OPUS THEOPHYLLINE
K885044 · KLS
Pb Diagnostic Systems, Inc.
Toxicology · 24d
Cleared Dec 28, 1988
PROCEDURE PACKS CONTRAST MEDIA SETS
K882717 · DTL
Procedure Packs, Inc.
Cardiovascular · 180d
Cleared Dec 28, 1988
EDENTRACE MULTI-CHARTER MODEL 3700
K883315 · DSF
Edentec Corp.
Cardiovascular · 145d
Cleared Dec 28, 1988
LIFEPAK 50 MONITOR/DEFIBRILLATOR
K883617 · LDD
Physio-Control Corp.
Cardiovascular · 126d
Cleared Dec 28, 1988
PERFECTA II TOTAL HIP SYSTEM
K883618 · JDI
Orthomet, Inc.
Orthopedic · 126d
Cleared Dec 28, 1988
CANDELA MINIFLEX DEFLECTABLE URETEROSCOPE
K884153 · FGB
Candela Laser Corp.
Gastroenterology & Urology · 89d
Cleared Dec 28, 1988
ALLERGAN LENS CASE
K884251 · LRX
Allergan Optical
Ophthalmic · 78d
Cleared Dec 28, 1988
UNIREST PL, ANTE./POST. RESTORATIVE, PASTE/LIQUID
K884351 · EBF
Scientific Pharmaceuticals, Inc.
Dental · 75d
Cleared Dec 28, 1988
THROMBIN-PREST REAGENT KIT
K884384 · GJA
American Bioproducts Co.
Hematology · 71d
Cleared Dec 28, 1988
FIBRI-PREST/THROMBIN-PREST CONTROLS
K884385 · GJA
American Bioproducts Co.
Hematology · 71d
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