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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
163513–163536 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 18, 1981
INTRODUCER, PERCUTANEOUS
K812143 · DYB
Willson
Cardiovascular · 21d
Cleared Aug 18, 1981
LKB-BROMMA 2218 HISTORANGE MICROTOME
K812157 · IDO
Lkb Instruments, Inc.
Hematology · 20d
Cleared Aug 18, 1981
PERCUSSOR
K812166 · BYI
Dhd Medical Products Div. Diemolding...
Anesthesiology · 19d
Cleared Aug 18, 1981
FLUSHFLO II
K812173 · KRA
Bentley Laboratories, Inc.
Cardiovascular · 15d
Cleared Aug 18, 1981
MIAMI, PROTRUSIO RING
K812182 · JDI
Zimmer, Inc.
Orthopedic · 15d
Cleared Aug 18, 1981
TIMETER-PRODUCED PURITAN BENNETT AIR ADP
K812183 · CAX
Timeter Instrument Corp.
Anesthesiology · 15d
Cleared Aug 18, 1981
NEPHELOMETRIC SOLID TURBIDITY STANDARD
K812220 · JIW
Hyland Therapeutic Div., Travenol...
Immunology · 12d
Cleared Aug 17, 1981
UVA SUN TANNING EQUIPMENT
K811870 · FTC
Cpc Systems, Inc.
Radiology · 47d
Cleared Aug 13, 1981
ESOPHAGEAL MOTILITY PROBE
K811083 · FFT
Konigsberg Instruments, Inc.
Gastroenterology & Urology · 114d
Cleared Aug 13, 1981
GLUCOSE OXIDASE RATE REAGENT
K811165 · CGA
Chem-Elec, Inc.
Chemistry · 107d
Cleared Aug 13, 1981
PACEPATH IMPLANTABLE ENDOCARD. PACING LD
K811200 · DTB
Pacesetter Systems
Cardiovascular · 105d
Cleared Aug 13, 1981
CHLORIDE REAGENT KIT
K811319 · JFS
Chem-Elec, Inc.
Chemistry · 93d
Cleared Aug 13, 1981
ULTRASONIC QFM SYSTEM 1000
K811376 · DPW
Narco Bio-Systems
Cardiovascular · 90d
Cleared Aug 13, 1981
ASTRA
K811381 · JFL
Chem-Elec, Inc.
Chemistry · 90d
Cleared Aug 13, 1981
CREATININE RATE REAGENT KIT
K811406 · CGX
Chem-Elec, Inc.
Chemistry · 86d
Cleared Aug 13, 1981
MODIFIED THORACENTESIS CATHETER
K811437 · KDQ
Blair Medical Products
General Hospital · 83d
Cleared Aug 13, 1981
MICRO-AIRE REPLACEMENT SAW BLADES
K811506 · GFA
Micro-Aire Surgical Instruments, Inc.
General & Plastic Surgery · 78d
Cleared Aug 13, 1981
SPACELABS' SYSTEM AUTORECORDER
K811540 · DSF
Spacelabs, Inc.
Cardiovascular · 73d
Cleared Aug 13, 1981
ARRHYTHMIA FUNCTION BLOCK
K811581 · DSI
Honeywell, Inc.
Cardiovascular · 69d
Cleared Aug 13, 1981
F72T12/BL-S/HO UVA SUNLAMP
K811585 · FTC
Westinghouse Electric Corp.
Radiology · 69d
Cleared Aug 13, 1981
F72T12/BL-S/SHO-O UVA SUNLAMP
K811586 · FTC
Westinghouse Electric Corp.
Radiology · 69d
Cleared Aug 13, 1981
BACH-SIMPSON MODEL BVM30
K811615 · DPW
Bach-Simpson , Ltd.
Radiology · 66d
Cleared Aug 13, 1981
BACH-SIMPSON MODEL TS266
K811616 · DPW
Bach-Simpson , Ltd.
Radiology · 66d
Cleared Aug 13, 1981
RUBELLA LATEX CARD TEST
K811637 · DOK
Bd Becton Dickinson Vacutainer...
Microbiology · 64d