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
127777–127800 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 02, 1990
MATRIX(TM)-96
K896202 · JJJ
Canberra Industries, Inc.
Chemistry · 68d
Cleared Jan 02, 1990
TITANIUM LIGATING CLIPS
K896262 · HBT
Richard-Allan Medical Ind., Inc.
General & Plastic Surgery · 64d
Cleared Jan 02, 1990
DYONICS SHOULDER PORTAL SYSTEM
K896416 · HRX
Dyonics, Inc.
Orthopedic · 55d
Cleared Jan 02, 1990
AUTOSCEPTOR
K896447 · LRG
Bd Becton Dickinson Vacutainer...
Microbiology · 54d
Cleared Jan 02, 1990
DOCUMENT(TM) TOTAL AND DIRECT BILIRUBIN LINEARITY
K896522 · JJY
Casco Standards
Chemistry · 48d
Cleared Jan 02, 1990
LYTENING(TM) 5, LYTENING(TM) SYSTEM 30
K896526 · JGS
Baxter Healthcare Corp
Chemistry · 50d
Cleared Jan 02, 1990
MEDX CERVICAL EXTENSION TEST & REHAB MACHINE
K896553 · IKK
Medx Corp.
Physical Medicine · 46d
Cleared Jan 02, 1990
MAL LATEX EXAMINATION GLOVES
K896604 · LYY
Pt. Maja Agung Latexindo
General Hospital · 42d
Cleared Jan 02, 1990
MODIFIED FSH ENZYME IMMUNOASSAY TEST KIT
K896640 · CGJ
Medix Biotech, Inc.
Chemistry · 39d
Cleared Jan 02, 1990
AMDEV LYTENING 2 SODIUM/POTASSIUM/LITHIUM/ANALYZER
K896692 · CEM
Baxter Healthcare Corp
Chemistry · 35d
Cleared Jan 02, 1990
ARTHRODISTRACTOR
K896770 · HRX
Arthroplastics, Inc.
Orthopedic · 33d
Cleared Jan 02, 1990
OPUS CARBAMAZEPINE TEST SYSTEM
K896860 · KLT
Pb Diagnostic Systems, Inc.
Toxicology · 28d
Cleared Jan 02, 1990
OPUS PHENYTOIN TEST SYSTEM
K896868 · LGR
Pb Diagnostic Systems, Inc.
Toxicology · 26d
Cleared Jan 02, 1990
CHIROPRACTIC MASSAGE PILLOW
K896947 · IRO
Intl. Pacific Industrial Corp. (Usa),...
Physical Medicine · 20d
Cleared Jan 02, 1990
ANTINUCLEAR ANTIBODY (ANA) TEST SYSTEM
K897025 · DHN
Zeus Scientific, Inc.
Immunology · 14d
Cleared Jan 02, 1990
CBC-CAL(TM) PLUS HEMATOLOGY CALIBRATOR/MULTIPLE
K897060 · KSA
R&D Systems, Inc.
Hematology · 15d
Cleared Dec 29, 1989
SIMULTEST IMK FOR FACS ANALYZER OR FACSCAN
K890349 · GKZ
Becton Dickinson Immunocytometry Systems
Hematology · 339d
Cleared Dec 29, 1989
MULTIPLE-VARIOUS TYPES OF ABSORBENT INCONTINENCE
K891986 · KME
Mark One Healthcare Products
General Hospital · 276d
Cleared Dec 29, 1989
MODEL 4000 EVOKED POTENTIAL MEASUREMENT SYSTEM
K894608 · GWF
Micro-Shev , Ltd.
Neurology · 164d
Cleared Dec 29, 1989
SQA
K894949 · POV
United Medical Systems, Inc.
Hematology · 148d
Cleared Dec 29, 1989
MICRORUPTOR III SYST, Q-SWITCHED ND:YAG LASER COMP
K895864 · LXS
Lasag AG
Ophthalmic · 87d
Cleared Dec 29, 1989
CYTO-STAT/COULTER CLONE T4-RD1/T8-FITC MONO ANTI
K895917 · GKZ
Coulter Immunology
Hematology · 80d
Cleared Dec 29, 1989
EVOLUTION HIP SYSTEM
K896105 · KWL
Dow Corning Wright
Orthopedic · 70d
Cleared Dec 29, 1989
ORTHO* RUBELLA-G ANTIBODY ELISA TEST
K896479 · LFX
Ortho Diagnostic Systems, Inc.
Microbiology · 46d