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
130657–130680 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 19, 1989
POROUS GENESIS PATELLAR AND STEMLESS TIBIAL COMP.
K890132 · JWH
Richards Medical Co., Inc.
Orthopedic · 188d
Cleared Jul 19, 1989
SIM 4000I ULTRASOUND SYSTEM-TRANSDUCER FOR SM 24/4
K890963 · IYO
Esaote Biomedica Elettronica
Radiology · 142d
Cleared Jul 19, 1989
FEMORAL HEADS/MODULAR & FIXED W/ TITAN NITRIDE SUR
K892059 · LZY
Protek, Inc.
Orthopedic · 112d
Cleared Jul 19, 1989
POROUS GENESIS STEMMED TIBIAL COMPONENT
K892366 · JWH
Richards Medical Co., Inc.
Orthopedic · 104d
Cleared Jul 19, 1989
P.F.C. MODULAR KNEE SYSTEM, TIBIAL TRAY-POROUS
K892394 · JWH
Johnson & Johnson Professionals, Inc.
Orthopedic · 103d
Cleared Jul 19, 1989
INTERSPEC TRANSESOPHAGEAL PROBE MODEL 4515
K892944 · JOP
Interspec, Inc.
Cardiovascular · 89d
Cleared Jul 19, 1989
CATHSCANNER(R) INTRAVASCULAR ULTRA IMAGING SYSTEM
K893042 · IYN
Endosonics Corp.
Radiology · 86d
Cleared Jul 17, 1989
BIOPSY KIT
K892389 · LRO
I M, Inc.
General & Plastic Surgery · 101d
Cleared Jul 14, 1989
EPSTEIN-BARR VIRAL CAPSID ANTIGEN IGG #4590
K883870 · LSE
Clinical Sciences, Inc.
Microbiology · 304d
Cleared Jul 14, 1989
EPSTEIN-BARR VIRAL CAPSID ANTIGEN IGM #5590
K883871 · LSE
Clinical Sciences, Inc.
Microbiology · 304d
Cleared Jul 14, 1989
NEUROTRAIN
K883896 · LIH
Sterne Equipment Co., Ltd.
Neurology · 303d
Cleared Jul 14, 1989
SURGICAL GLOVES
K884495 · KGO
Sanko Chemical Industry Co., Ltd.
General Hospital · 275d
Cleared Jul 14, 1989
BASAL/BOLUS INFUSORS
K884505 · FRN
Baxter Healthcare Corp
General Hospital · 262d
Cleared Jul 14, 1989
CARDIOCAP(TM) DR-104 REPORTER
K885058 · DSF
Datex Division Instrumentarium Corp.
Cardiovascular · 219d
Cleared Jul 14, 1989
MYOPORE(TM) UNIPOLAR SUTURELESS MYOCARDIAL LEADS
K885175 · DTB
Possis Medical, Inc.
Cardiovascular · 212d
Cleared Jul 14, 1989
BLADDER CYCLER CLOSED-SYSTEM URINARY DRAIN BAG
K890096 · FCN
Medical Inventors Corp., Inc.
Gastroenterology & Urology · 185d
Cleared Jul 14, 1989
ILO88 OTODYNAMIC ANALYZER SCREENING AUDIOMETER
K890124 · EWO
Grason-Stadler, Inc.
Ear, Nose, Throat · 184d
Cleared Jul 14, 1989
DISPOSABLE TRANSDUCER MANIFOLD
K890676 · DTL
L.O.N. Research, Inc.
Cardiovascular · 155d
Cleared Jul 14, 1989
OVERDENTURE - STUD ATTACHMENT
K890713 · DZE
Austenal Dental, Inc.
Dental · 151d
Cleared Jul 14, 1989
MYOTEST DBS NERVE STIMULATOR
K890746 · BXN
Biometer Intl. A/S
Anesthesiology · 151d
Cleared Jul 14, 1989
PATIENT EXAMINATION GLOVES
K890858 · LYY
Rejuvena Ent. Co. , Ltd.
General Hospital · 143d
Cleared Jul 14, 1989
LATEX EXAMINATION GLOVES (MFG. NINGBO MEDICAL)
K890891 · LYY
Interpro Intl., Inc.
General Hospital · 142d
Cleared Jul 14, 1989
PATIENT EXAMINATION GLOVE
K890974 · LYY
Barriermed, Inc.
General Hospital · 137d
Cleared Jul 14, 1989
NR LATEX EXAMINATION GLOVES
K891010 · LYY
Universal Bodycare (I) Sdn. Bhd.
General Hospital · 136d