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
132097–132120 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 01, 1989
OBSTETRICAL SAFETY SYSTEM
K884868 · KNC
Buckman Co., Inc.
Obstetrics & Gynecology · 100d
Cleared Mar 01, 1989
CIMPAT S TEMPORARY DENTAL CEMENT
K885007 · EMA
Specialites Septodont
Dental · 90d
Cleared Mar 01, 1989
WIDEX BTE HEARING AID MODEL Q8
K885128 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 79d
Cleared Mar 01, 1989
KOTEX SECURITY TUBE TAMPONS
K885194 · HEB
Kimberly-Clark Corp.
Obstetrics & Gynecology · 75d
Cleared Mar 01, 1989
FLOW THRU 16,18,20,22 FR REPLACE. GASTRO TUBE KIT
K885339 · KNT
Superior Healthcare Group, Inc.
Gastroenterology & Urology · 63d
Cleared Mar 01, 1989
INTERTECH UNIVERSAL HYDROPHOBIC FILTER
K890346 · CAH
Intertech/Ohio
General Hospital · 37d
Cleared Mar 01, 1989
MIDWIFERY/OBSTETRICAL FORCEPS
K890385 · HDA
Kinetic Medical Products
Obstetrics & Gynecology · 37d
Cleared Mar 01, 1989
KODAK X-OMATIC RA CASSETTE
K890750 · IXA
Eastman Kodak Company
Radiology · 16d
Cleared Feb 28, 1989
BT-1 INFUSION PUMP
K881759 · FRN
Ferring Laboratories, Inc.
General Hospital · 309d
Cleared Feb 28, 1989
M.I.P. - PUMP
K882249 · FRN
Intro-Med, Inc.
General Hospital · 273d
Cleared Feb 28, 1989
N.M.D.C. USER PROTECTIVE HYPODERMIC SYRINGE SYSTEM
K883073 · FMF
National Medical Device Corp.
General Hospital · 223d
Cleared Feb 28, 1989
LIFECARE MICRO PUMP
K883796 · FRN
Abbott Laboratories
General Hospital · 174d
Cleared Feb 28, 1989
INFUSION FLUID WARMER
K883873 · LGZ
Pmt Corp.
General Hospital · 168d
Cleared Feb 28, 1989
MONOPLACE HYPERBARIC EXTENSION SET (L 11055)
K884141 · FPA
Abbott Laboratories
General Hospital · 151d
Cleared Feb 28, 1989
MAGLINTE ENTEROCLYSIS CATHETER
K884379 · FGD
Lafayette Pharmacal, Inc.
Gastroenterology & Urology · 133d
Cleared Feb 28, 1989
EP-100 (SERIES)
K884415 · FPD
Stereotactic Medical Systems, Inc.
Gastroenterology & Urology · 131d
Cleared Feb 28, 1989
ZINETICS(R) EMC
K884527 · KLA
Zinetics Medical, Inc.
Gastroenterology & Urology · 124d
Cleared Feb 28, 1989
DREYER CURVED ENDOILLUMINATOR
K884556 · HQE
Advanced Surgical Products, Inc.
Ophthalmic · 120d
Cleared Feb 28, 1989
NEVISCAN MODEL N - 100
K884989 · HKI
Special Products, Inc.
Hematology · 89d
Cleared Feb 28, 1989
SIEMENS PACS/1-B (OPTICAL DISK OPTION)
K884995 · LLZ
Siemens Gammasonics, Inc.
Radiology · 89d
Cleared Feb 28, 1989
SHAPIRO CUTTER
K890544 · HQE
H.S. Intl. Co., Inc.
Ophthalmic · 25d
Cleared Feb 28, 1989
CP&S DISPOSABLE URINARY LEGBAG (MEDIUM & LARGE)
K890550 · KNX
Consolidated Products & Services, Inc.
Gastroenterology & Urology · 22d
Cleared Feb 28, 1989
URINARY DRAINAGE UNIT
K890551 · KNX
Consolidated Products & Services, Inc.
Gastroenterology & Urology · 22d
Cleared Feb 28, 1989
STICK-GARD SAFETY NEEDLE
K890620 · FMI
Ziehm International, Inc.
General Hospital · 21d