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
133897–133920 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 10, 1988
INSTRUMENTARIUM ULF MR IMAGING SYSTEM
K883621 · LNH
Instrumentarium Corp.
Radiology · 77d
Cleared Nov 10, 1988
PROBE(TM) MODELS 700 AND 1000
K883749 · JQW
Packard Instrument Co., Inc.
Chemistry · 70d
Cleared Nov 10, 1988
CIBA CORNING BLOOD COLLECTION CAPILLARY TUBE
K883813 · JKA
Ciba Corning Diagnostics Corp.
Chemistry · 63d
Cleared Nov 10, 1988
SHOULDER MICROSTRUCTURED HUMERAL PROSTHESIS
K883816 · KWS
Osteonics Corp.
Orthopedic · 63d
Cleared Nov 10, 1988
HYCOR SENTRY DRUGS OF ABUSE URINE CONTROL
K883942 · JJY
Icl Scientific
Toxicology · 52d
Cleared Nov 10, 1988
MAGNESIUM REAGENT (MAGON SULFONATE)
K883972 · JGJ
Sigma Chemical Co.
Chemistry · 51d
Cleared Nov 10, 1988
EMDS GLUCOSE (GLUC) TESTPACKS, NO. 67697/95
K884021 · CFR
Em Diagnostic Systems, Inc.
Chemistry · 49d
Cleared Nov 10, 1988
AMERLITE PROGESTERONE ASSAY, LAN.0079/2079 240/144
K884100 · JLS
Amersham Corp.
Chemistry · 43d
Cleared Nov 10, 1988
MACROPORE MEDICAL/SURGICAL PAPER TAPE
K884108 · KGX
Lectec Corp.
General & Plastic Surgery · 42d
Cleared Nov 10, 1988
MANUAL SURGICAL INSTRUMENTS (SEVERAL MODELS)
K884181 · GEN
Sales & Marketing Assoc.
General & Plastic Surgery · 38d
Cleared Nov 10, 1988
DELFIA (TM) HIGE KIT
K884545 · DGC
Pharmacia, Inc.
Immunology · 10d
Cleared Nov 10, 1988
LACTATE DEHYDROGENASE TEST (LD) ITEM NO. 65668
K884548 · CFJ
Em Diagnostic Systems, Inc.
Chemistry · 10d
Cleared Nov 10, 1988
ALKALINE PHOSPHATASE TEST (ALP) ITEM NO. 65651
K884549 · CJE
Em Diagnostic Systems, Inc.
Chemistry · 10d
Cleared Nov 09, 1988
SENSOCOR(TM) R-TEST 240 XL
K881772 · DXH
Sensormedix, Inc.
Cardiovascular · 197d
Cleared Nov 09, 1988
CONCEPT POWER SYSTEM
K881954 · HSZ
Concept, Inc.
Orthopedic · 183d
Cleared Nov 09, 1988
OEC-7102 ECG/NIBP MONITOR
K882254 · DPS
Nihon Kohden America, Inc.
Cardiovascular · 162d
Cleared Nov 09, 1988
ELECTRONIC DIGITAL BLOOD PRESSURE MONITOR
K882635 · DXN
Nihon Seimitsu Sokki Co., Ltd.
Cardiovascular · 135d
Cleared Nov 09, 1988
TRIAD-EP, PUSHBUTTON, CABLE INPUT TYPE
K883178 · DRO
Cardiotronics, Inc.
Cardiovascular · 105d
Cleared Nov 09, 1988
KIRSCHNER TC-IV/NON POR COAT/TOTAL CONDYLAR KNEE S
K883215 · JWH
Kirschner Medical Corp.
Orthopedic · 103d
Cleared Nov 09, 1988
TRAID-EP, PLATE INPUT, W/PULSE BLANKING CIRCUITRY
K883304 · DRO
Cardiotronics, Inc.
Cardiovascular · 98d
Cleared Nov 09, 1988
CARDIOBEEPER II
K883843 · DXH
Survival Technology, Inc.
Cardiovascular · 58d
Cleared Nov 09, 1988
SEAMED MODEL 3300 DUAL CHAMBER PACING SYSTEM ANALY
K883930 · DTE
Seamed Corp.
Cardiovascular · 55d
Cleared Nov 09, 1988
MODEL VY-800RA OPTIONAL ACCESSORY TO BSM 8500A
K883973 · DXJ
Nihon Kohden America, Inc.
Cardiovascular · 50d
Cleared Nov 09, 1988
MODEL 459 ELECTROCARDIOCORDER RECORDER
K884009 · DSH
Del Mar Avionics
Cardiovascular · 49d