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
161089–161112 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 14, 1982
STRATUS TDM CONTROL, LEVELS I,II,III
K820296 · DIF
American Dade
Chemistry · 99d
Cleared May 14, 1982
VD ALERT
K820520 · LIO
Intl. Research Distributors, Inc.
Microbiology · 77d
Cleared May 14, 1982
MECRON(R) ACETABULAR NETS TM
K820619 · FTM
Serrano Intl.
General & Plastic Surgery · 67d
Cleared May 14, 1982
VEIN-SHIELD
K820759 · KMK
Pan-Tech Research, Inc.
General Hospital · 53d
Cleared May 14, 1982
8700 CLINICAL CHEM. ANALYZER
K820888 · JJE
Boehringer Mannheim Corp.
Chemistry · 45d
Cleared May 14, 1982
MECRON VOORHOEVE TITANIUM SHEATH
K820899
Serrano Intl.
Orthopedic · 44d
Cleared May 14, 1982
BECKMAN MMC II METABOLIC MEAS. CART
K820905 · BZL
Beckman Instruments, Inc.
Anesthesiology · 43d
Cleared May 14, 1982
MAXI & MINI SHIELDS
K820960 · HHD
Dafoe & Dafoe, Inc.
Obstetrics & Gynecology · 38d
Cleared May 14, 1982
DISP. SKIN STAPLER REMOVALBLE SKINSTAPLE
K821024 · GDT
Howmedica Corp.
General & Plastic Surgery · 31d
Cleared May 14, 1982
ANESTHESIA BREATHING CIRCUIT
K821087 · CAI
Life Design Systems, Inc.
Anesthesiology · 25d
Cleared May 14, 1982
ACCUCHEK BG.
K821091 · CGA
Biodynamics Corp.
Hematology · 25d
Cleared May 14, 1982
A-LINER
K821096 · FMF
Martell Medical Products, Inc.
General Hospital · 24d
Cleared May 14, 1982
I-DHEA-SULFATE RIA KIT 125
K821145 · JKC
Nuclear Medical Systems, Inc.
Chemistry · 23d
Cleared May 14, 1982
ADHESIVE REMOVER
K821162 · KOX
The Healthcare Group Laboratories, Inc.
General & Plastic Surgery · 18d
Cleared May 14, 1982
URICASE (U.V.) URIC ACID
K821167 · CDO
Syn-Kit, Inc.
Chemistry · 17d
Cleared May 14, 1982
TSH-SQUIBB RADIOIMMUNOASSAY KIT
K821174 · JLW
Squibb & Sons, Inc.
Chemistry · 18d
Cleared May 14, 1982
GASTRIN RADIOIMMUNOASSAY KIT (125-I)
K821175 · CGC
Bd Becton Dickinson Vacutainer...
Chemistry · 18d
Cleared May 14, 1982
VISIDEX REAGENT STRIPS
K821179 · CGA
Miles Laboratories, Inc.
Chemistry · 17d
Cleared May 14, 1982
TARGET ISOCHECK CONTROL SERUM
K821183 · JJT
Smithkline Diagnostics, Inc.
Chemistry · 17d
Cleared May 14, 1982
CAMPY-S AGAR
K821218 · JSJ
Isle Media and Sterile Products, Inc.
Microbiology · 17d
Cleared May 14, 1982
DEKNATEL SKIN STAPLE EXTRACTOR
K821228 · GAG
Howmedica Corp.
General & Plastic Surgery · 17d
Cleared May 14, 1982
DISPOSABLE PLASTIC SYRINGE W/NEEDLE
K821233 · FMF
Taiyang Corp.
General Hospital · 17d
Cleared May 14, 1982
DISPOSABLE TEMPERATURE PROBE
K821244 · FLL
Shiley, Inc.
General Hospital · 15d
Cleared May 14, 1982
SELOFIX
K821257 · KGX
Selomas, Inc.
General & Plastic Surgery · 14d