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
73921–73944 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 04, 2002
HYALURONIDASE SOLUTION
K022931 · MQL
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 61d
Cleared Nov 04, 2002
VAGINAL SPECULUM, MODEL 5555S, 5555M, OR 5555L
K022948 · HIB
Medical Action Industries, Inc.
Obstetrics & Gynecology · 60d
Cleared Nov 04, 2002
CERANUM 50
K023199 · EJT
Sb Lucius, Inc.
Dental · 40d
Cleared Nov 04, 2002
CERANUM 76
K023200 · EJT
Sb Lucius, Inc.
Dental · 40d
Cleared Nov 04, 2002
HEMCON BANDAGE
K023298 · QSY
Hemcon, Inc.
General & Plastic Surgery · 32d
Cleared Nov 04, 2002
MEDLINE ASEP PLUS SURGICAL DRAPES
K023432 · KKX
Medline Industries, Inc.
General Hospital · 20d
Cleared Nov 04, 2002
DATEX-OHMEDA S/5 WEB VIEWER WITH L-6WV02 SOFTWARE
K023497 · MSX
Datex-Ohmeda
Cardiovascular · 17d
Cleared Nov 04, 2002
SIEMENS MULTIVIEW WORKSTATION MODIFICATIONS
K023569 · MHX
Siemens Medical Solutions USA, Inc.
Cardiovascular · 11d
Cleared Nov 04, 2002
PHYSIOLOGICAL MONITOR, MODEL 3000 (SERIES)
K023616 · DRT
Ivy Biomedical Systems, Inc.
Cardiovascular · 6d
Cleared Nov 01, 2002
PURE WATER SOLUTIONS CENTRAL WATER SYSTEM FOR HEMODIALYSIS
K011005 · FIP
Pure Water Solutions, Inc.
Gastroenterology & Urology · 576d
Cleared Nov 01, 2002
REGENECARE WOUND GEL
K020540 · SEJ
Mpm Medical., Inc.
General & Plastic Surgery · 255d
Cleared Nov 01, 2002
PURTIAN BENNETT, GOOD KNIGHT 420G MODEL M-113900-US
K020886 · BZD
Tyco Healthcare Nancy
Anesthesiology · 228d
Cleared Nov 01, 2002
STIMULAN - CALCIUM SULFATE BONE VOID FILLER KIT
K021551 · MQV
Biocomposites, Ltd.
Orthopedic · 172d
Cleared Nov 01, 2002
SYNTHES LOW PROFILE NEURO SYSTEM
K022012 · JEY
Synthes (Usa)
Dental · 134d
Cleared Nov 01, 2002
VITAL SCIENTIFIC APTT, APTT & QUIKCOAG APTT
K022021 · GFO
Vital Scientific N.V.
Hematology · 134d
Cleared Nov 01, 2002
THOMAS MEDICAL ELECTRODES
K022593 · HGI
Thomas Medical, Inc.
Obstetrics & Gynecology · 88d
Cleared Nov 01, 2002
PLAYTEX BREAST PUMP
K022594 · HGX
Playtex Products, Inc.
Obstetrics & Gynecology · 88d
Cleared Nov 01, 2002
K-FIX
K022597 · HTY
New Deal, S.A.
Orthopedic · 88d
Cleared Nov 01, 2002
AZOG, INC. HCG ONE-STEP URINE PREGNANCY TEST STRIP (DIPSTICK)
K022680 · DHA
Azog, Inc.
Chemistry · 81d
Cleared Nov 01, 2002
AZOG, INC. HCG ONE-STEP URINE PREGNANCY TEST (DEVICE OR CASSETTE)
K022681 · DHA
Azog, Inc.
Chemistry · 81d
Cleared Nov 01, 2002
STEPHENS DISPOSABLE FORCEPS
K022835 · HNR
Stephens Instruments
Ophthalmic · 66d
Cleared Nov 01, 2002
STEPHENS DISPOSABLE SPECULUM
K022836 · HNC
Stephens Instruments
Ophthalmic · 66d
Cleared Nov 01, 2002
STEPHENS DISPOSABLE SCISSORS
K022840 · HNF
Stephens Instruments
Ophthalmic · 66d
Cleared Nov 01, 2002
STEPHENS DISPOSABLE HOOKS
K022842 · HNQ
Stephens Instruments
Ophthalmic · 66d