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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
83065–83088 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Feb 07, 2000
LATEX EXAMINATION GLOVES-PRE-POWDERED-STERILE
K994255 · LYY
Pt. Maja Agung Latexindo
General Hospital · 52d
Cleared Feb 07, 2000
RESIN TOOTH BONDING AGENT
K994302 · KLE
Parkell, Inc.
Dental · 48d
Cleared Feb 07, 2000
ARABESK FLOW
K994304 · EBF
Voco GmbH
Dental · 48d
Cleared Feb 06, 2000
EXCELART WITH PIANISSIMO
K993803 · LNH
Toshiba America Mri, Inc.
Radiology · 89d
Cleared Feb 04, 2000
BARCOMED 2MP2
K000015 · LLZ
Barco N.V.
Radiology · 32d
Cleared Feb 04, 2000
ENTEC REFLEX WAND 55, MODEL E4055-00
K000036 · GEI
Arthrocare Corp.
General & Plastic Surgery · 29d
Cleared Feb 04, 2000
ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD, PLASMA...
K000074 · GEI
Arthrocare Corp.
General & Plastic Surgery · 24d
Cleared Feb 04, 2000
NIKOPAD ELECTROSURGICAL GROUNDING PAD, MODEL 4777M
K000079 · HAM
Nikomed U.S.A., Inc.
General & Plastic Surgery · 24d
Cleared Feb 04, 2000
QUICKSCREEN PRO MULTI DRUG SCREENING TEST, MODEL 9153 PAT04
K000131 · LDJ
Phamatech
Toxicology · 17d