FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
82153–82176 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 26, 2000
MACROPOREDX DISTRACTOR SYSTEM
K000992 · MQN
Macropore Biosurgery, Inc.
Dental · 90d
Cleared Jun 26, 2000
SMITH + NEPHEW RF ARTHROSCOPIC WAND SYSTEM
K001226 · HRX
Smith & Nephew, Inc.
Orthopedic · 70d
Cleared Jun 26, 2000
ADVIA IMS
K001344 · DIH
Bayer Corp.
Chemistry · 60d
Cleared Jun 26, 2000
INFINITY AMYLASE REAGENT (PROCEDURE NO. 580/568)
K001569 · JFJ
Sigma Diagnostics, Inc.
Chemistry · 38d
Cleared Jun 23, 2000
VIVANT MEDICAL BIOPSY MARKER SYSTEM
K000278 · FZP
Vivant Medical, Inc.
General & Plastic Surgery · 144d
Cleared Jun 23, 2000
HANWELLA LATEX PATIENT EXAM. GLOVES POWDER-FREE
K000351 · LYY
Hanwella Rubber Products , Ltd.
General Hospital · 140d
Cleared Jun 23, 2000
UNICOMPARTMENTAL PATELLOFEMORAL PROSTHESIS (UPP) CEMENTED
K000827 · KRR
Walter Abendschein, M.D.
Orthopedic · 101d
Cleared Jun 23, 2000
KLINIDRAPE SURGICAL DRAPES
K000906 · KKX
Molnlycke Health Care, Inc.
General Hospital · 94d
Cleared Jun 23, 2000
OPUS 10 DENTAL DIODE LASER
K000990 · GEX
Opusdent , Ltd.
General & Plastic Surgery · 87d
Cleared Jun 23, 2000
SULZER ORTHOPEDICS MS-30 FEMORAL STEM
K001078 · JDI
Sulzer Orthopedics, Inc.
Orthopedic · 80d
Cleared Jun 23, 2000
FRESENIUS COMBILINES LOW VOLUME BLOOD TUBING SET, MODELS 03-2291 (POST PUMP)...
K001107 · FJK
Fresenius Medical Care North America
Gastroenterology & Urology · 79d
Cleared Jun 23, 2000
AUDIO TECHNOLOGIES S:R.1
K001142 · ETB
Audio Technologies S.R.L.
Ear, Nose, Throat · 74d
Cleared Jun 23, 2000
POLYESTER NONABSORBABLE SURGICAL SUTURES URP
K001172 · GAT
Cp Medical
General & Plastic Surgery · 73d
Cleared Jun 23, 2000
NYLON, NONABSORBABLE SURGICAL SUTURES USP
K001173 · GAR
Cp Medical
General & Plastic Surgery · 73d
Cleared Jun 23, 2000
SILK, NONABSORBABLE, SURGICAL SUTURES, USP
K001184 · GAP
Cp Medical
General & Plastic Surgery · 73d
Cleared Jun 23, 2000
POLYPROPYLENE, NONABSORBABLE SURGICAL SUTURES USP
K001185 · GAW
Cp Medical
General & Plastic Surgery · 73d
Cleared Jun 23, 2000
ACULUX, MODEL AX3001, AX3002
K001223 · FQP
Aculux
General & Plastic Surgery · 67d
Cleared Jun 23, 2000
LATEX SURGEON SURGEON'S GLOVES POWDER-FREE WITH PROTEIN CONTENT LABELING...
K001274 · KGO
Pt. Maja Agung Latexindo
General Hospital · 64d
Cleared Jun 23, 2000
TRIFLANGE ACETABULAR CUP SYSTEM
K001277 · LPH
DePuy Orthopaedics, Inc.
Orthopedic · 63d
Cleared Jun 23, 2000
PLAIN AND CHROMIC GUT ABSORBABLE SURGICAL SUTURES USP
K001299 · GAL
Cp Medical
General & Plastic Surgery · 60d
Cleared Jun 23, 2000
PALCERAM 49
K001481 · EJT
Aurex SA (Pty) , Ltd.
Dental · 43d
Cleared Jun 23, 2000
AURENORM 75 KF
K001482 · EJT
Aurex SA (Pty) , Ltd.
Dental · 43d
Cleared Jun 23, 2000
DISPOSABLE PVC POWDERED SYNTHETIC EXAM GLOVES
K001601 · LYZ
Shanghai PT Plastics Enterprise...
General Hospital · 30d
Cleared Jun 23, 2000
DISPOSABLE POWDER FREE NITRILE EXAM GLOVE, GREEN COLOR
K001637 · LZA
Sheen More Ent. Co., Ltd.
General Hospital · 24d