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
159577–159600 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 21, 1982
EXTENSION SET TYPE DP
K822658 · FKX
Abbott Laboratories
Gastroenterology & Urology · 48d
Cleared Oct 21, 1982
INPERSOL-CAPD ADMINIS. SET TYPE DP
K822712 · FKX
Abbott Laboratories
Gastroenterology & Urology · 44d
Cleared Oct 21, 1982
ABBOTT LABORATORIES PROLACTIN EIA
K822759 · CFT
Abbott Laboratories
Chemistry · 37d
Cleared Oct 21, 1982
MDM ARTERIAL BLOOD GAS KIT
K822786 · CBT
Martell Medical Products, Inc.
Anesthesiology · 36d
Cleared Oct 21, 1982
YOSHIDA/KAYCOR X-70 X-RAY UNIT
K828325
The Yoshida Dental Mfg. Co., Ltd.
Radiology · 23d
Cleared Oct 20, 1982
FACE SHIELDS
K822004 · KNT
Kelleher Corp.
Gastroenterology & Urology · 104d
Cleared Oct 18, 1982
PECOR, PERCOR-DL, 10.5 FRENCH W/SMEC
K820882 · DSP
Datascope Corp.
Cardiovascular · 202d
Cleared Oct 18, 1982
DIALYZER REPROCESSING SYSTEM DRS-4
K821863 · LIF
Seratronics, Inc.
Gastroenterology & Urology · 116d
Cleared Oct 18, 1982
NON-STETHO 7, UM-15TP
K821989 · DXN
Hirata Sangyo Co. USA, Inc.
Cardiovascular · 103d
Cleared Oct 18, 1982
ALPHA-TOXIN DISCS
K821992 · JTO
Microchemical Specialities, Co.
Microbiology · 103d
Cleared Oct 18, 1982
SIEMENS SIRECUST SYSTEM
K822091
Analogic Corp.
Cardiovascular · 95d
Cleared Oct 18, 1982
SERAGAN ACTH125 I-RIA KIT
K822115 · CKG
Seragen Diagnostics, Inc.
Chemistry · 91d
Cleared Oct 18, 1982
LARYNGEAL SYRINGE
K822185 · FMF
Kelleher Corp.
General Hospital · 87d
Cleared Oct 18, 1982
BLOOD CELL DILUENT 78N 1913
K822325 · GIF
Interscience, Inc.
Hematology · 76d
Cleared Oct 18, 1982
BLENDED DETERGENT-78N 1912-1
K822326 · PPM
Interscience, Inc.
Hematology · 76d
Cleared Oct 18, 1982
SURGICARE MODEL 1000
K822447
Surgicare Scientific Laboratory, Inc.
General & Plastic Surgery · 63d
Cleared Oct 18, 1982
SYRINGE PUMP 209-100
K822454 · FRN
Medix Corp.
General Hospital · 63d
Cleared Oct 18, 1982
CRITICAL MEASUREMENT UNIT
K822556 · BYZ
Bemis Health Care
General Hospital · 55d
Cleared Oct 18, 1982
SPECIMEN ADAPTOR
K822557 · BYZ
Bemis Health Care
General Hospital · 55d
Cleared Oct 18, 1982
TEFLON COATED GUIDE WIRES & CATHETER
K822586 · DQX
Universal Medical Instrument Corp.
Cardiovascular · 53d
Cleared Oct 18, 1982
LS6 ARRYTHMIA DISCRIMINATOR
K822616 · DSI
Life Science Instrumentation, Inc.
Cardiovascular · 49d
Cleared Oct 18, 1982
C-200 INFANT INCUBATOR
K822656 · FMZ
Narco Scientific
General Hospital · 45d
Cleared Oct 18, 1982
CLEAN-N-SOAK
K822707 · HPX
Allergan, Inc.
Ophthalmic · 41d
Cleared Oct 18, 1982
HEMOTECT
K822731 · KHE
Bio-Chem Laboratories
Hematology · 35d