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
142009–142032 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 22, 1986
MEDI-PLAST DISPOSABLE MANIFOLD
K863402 · DTL
Medi-Plast Intl., Inc.
Cardiovascular · 49d
Cleared Oct 22, 1986
OBSTETRICAL KIT
K863504
Dyna-Med
Obstetrics & Gynecology · 43d
Cleared Oct 22, 1986
OXY-OFF(TM)
K863510 · BXY
B&B Medical Technologies, Inc.
Anesthesiology · 43d
Cleared Oct 22, 1986
I.V. START KIT, STERILE, DISPOSABLES
K863712 · LRS
Busse Hospital Disposables, Inc.
General & Plastic Surgery · 29d
Cleared Oct 21, 1986
SOLUTION B- NA 50MEQ/L, K 40 MEQ/L
K863502 · JIX
Reagent Laboratory, Inc.
Chemistry · 42d
Cleared Oct 21, 1986
ULTRAWASH I
K863623 · JQW
Dynatech Laboratories, Inc.
Chemistry · 35d
Cleared Oct 21, 1986
ULTRAWASH II
K863624 · JQW
Dynatech Laboratories, Inc.
Chemistry · 35d
Cleared Oct 20, 1986
TECHNICON RA-XT SYSTEM WITH ANALYTES
K862561 · JJC
Technicon Instruments Corp.
Chemistry · 109d
Cleared Oct 20, 1986
SYNECTICS MOTILITY SYSTEM
K862929 · FFT
Synectics-Dantec
Gastroenterology & Urology · 89d
Cleared Oct 20, 1986
MEDITRADE ARTIFICIAL EYES AND IMPLANTS
K862977 · HPZ
Meditrade, Inc.
Ophthalmic · 74d
Cleared Oct 20, 1986
OXYGENATOR MODEL NO. BENTLEY-10 PLUS
K863249 · DTZ
American Bentley
Cardiovascular · 59d
Cleared Oct 20, 1986
IQ IMMUNOCHEMISTRY SYSTEM
K863531 · JJE
Bd Becton Dickinson Vacutainer...
Chemistry · 40d
Cleared Oct 20, 1986
OPHTHALMIC SURGICAL DRAPE
K863662
Myocure, Inc.
Ophthalmic · 32d
Cleared Oct 20, 1986
OPHTHALMIC SURGICAL OCULAR MARKERS
K863663 · HMR
Myocure, Inc.
Ophthalmic · 32d
Cleared Oct 20, 1986
THE SAVER KIT
K863666
Myocure, Inc.
Ophthalmic · 32d
Cleared Oct 20, 1986
STEINMANN(THREADED/CALIBRATED),KNOWLES&HOGIE PINS
K863734 · HTY
Micro-Aire Surgical Instruments, Inc.
Orthopedic · 27d
Cleared Oct 20, 1986
RK VACUUM FIXATION RING SYSTEM
K863775 · HNH
Ameritek, Inc.
Ophthalmic · 24d
Cleared Oct 20, 1986
MILITARY PRESCRIPTION FRAME
K863862 · HQZ
Halo Optical Products, Inc.
Ophthalmic · 17d
Cleared Oct 20, 1986
RAINCOAT
K863910 · BZO
Artec Environmental Monitoring Division
Anesthesiology · 12d
Cleared Oct 20, 1986
VERSAFLEX(TM) DELTA ST(TM) MONITOR
K863922 · DSH
Versaflex Delivery Systems, Inc.
Cardiovascular · 12d
Cleared Oct 17, 1986
STUDEX EAR PIERCING GUNS
K860622 · JYS
Onyx Industries, Inc.
Ear, Nose, Throat · 240d
Cleared Oct 17, 1986
DP32 HAND HELD DENTAL PROPHYLAXIS UNIT
K861601 · EIA
Stewart J. Lustgarten
Dental · 171d
Cleared Oct 17, 1986
AUTO-VAC (TM) AUTOTRANSFUSION RESERV, MODEL 7900
K862684 · CAC
Boehringer Laboratories
Anesthesiology · 94d
Cleared Oct 17, 1986
CHLAMYDIA TISSUE CULTURE CONFIRMATION TEST (EIA)
K862948 · LJC
Intercare Diagnostics, Inc.
Microbiology · 73d