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
128353–128376 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 07, 1989
PATIENT EXAMINATION GLOVES
K891182 · LYY
Raystar Engineering & Construction...
General Hospital · 246d
Cleared Nov 07, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892076 · LYY
M/S Shanghai Knitwear Import & Export...
General Hospital · 218d
Cleared Nov 07, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892571 · LYY
Sinopac Marketing, Inc.
General Hospital · 211d
Cleared Nov 07, 1989
PATIENT EXAMINATION GLOVES
K893075 · LYY
Quality Latex Corp. Sdn Bhd
General Hospital · 208d
Cleared Nov 07, 1989
LATEX EXAMINATION GLOVES
K893804 · LYY
S-P Pantec Co., Ltd.
General Hospital · 169d
Cleared Nov 07, 1989
LATEX EXAM GLOVES (MFG: CHINA NAT CHEM CONST CORP)
K894194 · LYY
Invent Ent. (U.S.A.) Corp.
General Hospital · 146d
Cleared Nov 07, 1989
WESTCO MADAYAG PAB NEEDLE
K894387 · HAW
Western Medical, Ltd.
Neurology · 113d
Cleared Nov 07, 1989
LATEX PATIENT EXAMINATION GLOVES
K894967 · LYY
Yan Ling Rubber Products Co.
General Hospital · 92d
Cleared Nov 07, 1989
HEIMLICH MICRO TRACH
K895130 · BTO
Ballard Medical Products
Anesthesiology · 82d
Cleared Nov 07, 1989
BLOOD GAS SAFETY SYRINGE
K895171 · CBT
Kronner Medical
Anesthesiology · 89d
Cleared Nov 07, 1989
INTRASITE CAVITY WOUND DRESSING
K895354 · KOZ
Smith & Nephew United, Inc.
General & Plastic Surgery · 67d
Cleared Nov 06, 1989
ELECTRO NEUROMUSCULAR STIMULATOR MODEL 2000
K884651 · IPF
Biomedical Life Systems, Inc.
Physical Medicine · 364d
Cleared Nov 06, 1989
BIOPRO ANATOMIC UNICOMPARTMENTAL KNEE
K890044 · HRY
Biopro, Inc.
Orthopedic · 305d
Cleared Nov 06, 1989
CCO SYSTEM MODEL SP1467,SP5567,SP6267
K892941 · KRB
Spectramed, Inc.
Cardiovascular · 199d
Cleared Nov 06, 1989
SMT-50A MAGNETIC RESONANCE IMAGING SYSTEM
K893744 · LNH
Shimadzu Medical Systems
Radiology · 172d
Cleared Nov 06, 1989
ACETABULAR SHELLS & LINERS FOR ATH TOTAL HIP SYST.
K893821 · JDI
Kinamed, Inc.
Orthopedic · 167d
Cleared Nov 06, 1989
THERASTIM
K893851 · IPF
Physiodynamics, Inc.
Physical Medicine · 165d
Cleared Nov 06, 1989
TOITU FETAL ACTOCARDIOGRAPH, MT-332
K894036 · HGM
Toitu of America, Inc.
Obstetrics & Gynecology · 153d
Cleared Nov 06, 1989
ULTRANET-S COLLIMATOR
K894142 · IZW
GE Medical Systems
Radiology · 146d
Cleared Nov 06, 1989
ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL
K894514 · JWY
Alamar Biosciences Laboratory, Inc.
Microbiology · 110d
Cleared Nov 06, 1989
HP MODEL M1318A TRANSVAGINAL ULTRASOUND TRANSDUCER
K895026 · HGL
Hewlett-Packard Co.
Obstetrics & Gynecology · 90d
Cleared Nov 06, 1989
MODEL 410T TELECOMMUNICATION SYSTEM
K895045 · HGM
Ge Medical Systems Information...
Obstetrics & Gynecology · 89d
Cleared Nov 06, 1989
ARROW HANDS-OFF THERMO-PACE
K895268 · DQO
Arrow Intl., Inc.
Cardiovascular · 75d
Cleared Nov 06, 1989
ULTIMA XS MICROCURRENT TENS
K895295 · GZJ
American Imex
Neurology · 73d