Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
142609–142632 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Oct 17, 1986
IMPROVED COMSPAN
K863552 · EBF
Dentsply Intl.
Dental · 35d
Cleared Oct 17, 1986
ACTIN FSL ACTIVATED PTT REAGENT
K863594 · GGW
American Dade
Hematology · 32d
Cleared Oct 17, 1986
ROTARY* POWERED SCALPEL
K863731 · GEI
Self Sharpening Surgical Steel, Inc.
General & Plastic Surgery · 24d
Cleared Oct 17, 1986
FOUNDATIONS PLUS FACIAL-CHIN-NECK SUPPORTER 1000
K863754
Foundations Plus, Inc.
General & Plastic Surgery · 22d
Cleared Oct 16, 1986
BAUSCH & LOMB CLEANING PAD
K843511 · LPN
Bausch & Lomb, Inc.
Ophthalmic · 770d
Cleared Oct 16, 1986
KONTRON VITALMON 5010 PATIENT MONITOR
K852249 · BZQ
Kontron Instruments, Inc.
Anesthesiology · 511d
Cleared Oct 16, 1986
PATIENT MON 1280/1281/120C/121C & MULTI-PARA CART
K860646 · DPS
Analogic Corp.
Cardiovascular · 238d
Cleared Oct 16, 1986
MODEL 545-45 FOR NEUROLOGICAL SURGICAL APPLICATION
K860977 · LLF
Britt Corp., Inc.
Neurology · 216d
Cleared Oct 16, 1986
HS-15M MICROWAVE SURGERY EQUIPMENT, MICROTAZE
K861904 · KNS
Cooper Lasersonics, Inc.
Gastroenterology & Urology · 153d
Cleared Oct 16, 1986
HEPACRON PUREAIR-ZONE SYSTEM
K862432 · FRF
Hepacron, Inc.
General Hospital · 112d