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
83569–83592 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 08, 2000
ARTHRO-SURGIMAT-A103
K000153 · HRX
W.O.M. World of Medicine GmbH
Orthopedic · 21d
Cleared Feb 08, 2000
CLICK'X
K992739 · MNH
Synthes Spine
Orthopedic · 176d
Cleared Feb 08, 2000
ANTEGRADE/RETROGRADE PERFUSION ADAPTER WITH OR WITHOUT PRESSURE LINE
K993818 · DWF
California Medical Laboratories, Inc.
Cardiovascular · 90d
Cleared Feb 08, 2000
CEREC 3
K994172 · ELW
Sirona Dental Systems GmbH
Dental · 60d
Cleared Feb 08, 2000
SUTRALON NYLON SUTURES
K994176 · GAR
Visionary Medical Supplies, Inc.
General & Plastic Surgery · 60d
Cleared Feb 08, 2000
SUTRASILK SILK SUTURE
K994177 · GAP
Visionary Medical Supplies, Inc.
General & Plastic Surgery · 60d
Cleared Feb 08, 2000
SPETZLER ROUND HANDLE APPLIERS, MODELS C-3753, C-3753T, C-3754, C-3754T
K994191 · HCI
Nmt Medical, Inc.
Neurology · 57d
Cleared Feb 08, 2000
FRONTAL SINUS TREPHINATION CANNULA
K994262 · KAM
Xomed, Inc.
General & Plastic Surgery · 53d
Cleared Feb 08, 2000
BITX PROBES
K994336 · GEI
Everest Medical Corp.
General & Plastic Surgery · 47d
Cleared Feb 07, 2000
NOVABONE-BIOGLASS BONE GRAFT PARTICULATE
K000149 · LYC
Usbiomaterials Corp.
Dental · 19d
Cleared Feb 07, 2000
PAR 5 ACETABULAR COMPONENT
K000254 · JDI
Biomet, Inc.
Orthopedic · 10d
Cleared Feb 07, 2000
HUMAN SERUM ALBUMIN
K991392 · MQL
Advanced Reproductive Technologies
Obstetrics & Gynecology · 292d
Cleared Feb 07, 2000
THE MARGRON HIP REPLACEMENT SYSTEM
K992815 · MEH
Portland Orthopaedics Pty. , Ltd.
Orthopedic · 171d
Cleared Feb 07, 2000
ARTIFICIAL TEETH (ACRYLIC TEETH)
K992854 · ELM
Masterdent Ltda.
Dental · 167d
Cleared Feb 07, 2000
PLATEX ODER ABSORBING GENTLE GLIDE, SLIMFITS AND SILK GLIDE TAMPONS
K993794 · HEB
Playtime Products, Inc.
Obstetrics & Gynecology · 90d
Cleared Feb 07, 2000
GYNECARE LAPAROSCOPIC MORCELLATOR
K993801 · HET
Ethicon, Inc.
Obstetrics & Gynecology · 90d
Cleared Feb 07, 2000
KSEA RIGID CULDOSCOPE AND ACCESSORIES
K993804 · HEW
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 90d
Cleared Feb 07, 2000
POWDER-FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA
K993876 · LZA
Shen Wei (Usa), Inc.
General Hospital · 84d
Cleared Feb 07, 2000
DISPOSABLE INFUSION PUMP KIT
K993972 · MEB
Biomet, Inc.
General Hospital · 76d
Cleared Feb 07, 2000
AMBIDERM POWDERFREE LATEX EXAMINATION GLOVES WITH A PROTEIN CLAIM OF 50...
K994131 · LYY
Medtaxx Partners
General Hospital · 62d
Cleared Feb 07, 2000
RUBBERCARE POWDER-FREE, GUARDIAN POWDER-FREE LATEX EXAM GLOVES WITH PROTEIN...
K994201 · LYY
Perusahaan Pelindung Getah (M) Sdn Bhd
General Hospital · 56d
Cleared Feb 07, 2000
SENSI-PRO DISPOSABLE POWDERED VINYL SYNTHETIC EXAMINATION GLOVES, BEIGE COLOR
K994206 · LYZ
Shijiazhuang Hongray Plastic Products...
General Hospital · 55d
Cleared Feb 07, 2000
SENSI-PRO DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES, BEIGE COLOR
K994222 · LYZ
Shijiazhuang Hongray Plastic Products...
General Hospital · 54d
Cleared Feb 07, 2000
TEKMEDIC POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING...
K994250 · LYY
Tekmedic (M) Sdn Bhd
General Hospital · 53d