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
136777–136800 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 03, 1988
ZENITH TRAVELER CHIROPRACTIC TABLE
K880222 · INW
Williams Manufacturing Co.
Physical Medicine · 14d
Cleared Feb 03, 1988
RESUBMITTED EXCALIBUR
K880271 · ISD
Quinton, Inc.
Physical Medicine · 13d
Cleared Feb 02, 1988
PIE MEDICAL SCANNER 1000
K870058 · KNG
Pie Data Medical BV
Obstetrics & Gynecology · 391d
Cleared Feb 02, 1988
ULTRASOUND LINEAR/SECTOR SCANNER 1100
K870653 · KNG
Pie Data Medical BV
Obstetrics & Gynecology · 350d
Cleared Feb 02, 1988
GLUCOSCOT II BLOOD GLUCOSE TEST SYSTEM
K870708 · LFR
Kyoto Daiichi Kagaku Co., Ltd.
Chemistry · 347d
Cleared Feb 02, 1988
MODEL 20-C W/BR-20A/U ATTACH/MODEL HL-3.0 OB/GYN
K870841 · HHR
Directed Energy, Inc.
Obstetrics & Gynecology · 341d
Cleared Feb 02, 1988
MODEL 20-C, RL-20A/U, OB-10A/U
K872709 · HHR
Directed Energy, Inc.
Obstetrics & Gynecology · 210d
Cleared Feb 02, 1988
OVEIA (TM) DUAL ANALYTE
K872843 · JLP
Boots-Celltech Diagnostics, Inc.
Chemistry · 197d
Cleared Feb 02, 1988
OHMEDA 4700 OXICAP MONITOR
K873199 · DQA
Ohmeda Medical
Anesthesiology · 173d
Cleared Feb 02, 1988
SURGI-LIGHT DISPOS.FIBEROPTIC DEL/SYS GI/URO USE
K873892 · LNK
Laserguide
Gastroenterology & Urology · 132d
Cleared Feb 02, 1988
PTI HEART-CHILL POUCH/PAD SLING (STERILE)
K873924 · DWC
Buckman Co., Inc.
Cardiovascular · 130d
Cleared Feb 02, 1988
MEDTRONIC MODEL 4016A ENDOCARDIAL PACING LEAD
K873962 · DTB
Medtronic Vascular
Cardiovascular · 126d
Cleared Feb 02, 1988
BETA-HCG ASSAY
K873986 · DHA
Schiff & Co.
Chemistry · 126d
Cleared Feb 02, 1988
MODIFIED CALCITONIN RIA KIT DSL #1200
K874087 · JKR
Diagnostic Systems Laboratories, Inc.
Chemistry · 118d
Cleared Feb 02, 1988
ENDOCARDIAL SCREW-IN LEAD, MODEL 1018T
K874205 · DTB
Pacesetter Systems
Cardiovascular · 110d
Cleared Feb 02, 1988
QUANTIMETRIX TOTAL CREATINE KINASE CONTROL
K874302 · JJT
Quantimetrix Medical Industries
Chemistry · 105d
Cleared Feb 02, 1988
HI-LO TEMP(R) MYOCARDIAL TEMPERATURE SENSOR
K874605 · KRI
Mallinckrodt Critical Care
Cardiovascular · 85d
Cleared Feb 02, 1988
STERILIZATION OF DEVICES BY RADIATION
K874659 · BTT
Inhalation Plastics
Anesthesiology · 105d
Cleared Feb 02, 1988
PULSEMATE BX-5
K874692 · DQA
Colin Medical Instruments Corp.
Anesthesiology · 78d
Cleared Feb 02, 1988
GAMOW HYPERBARIC BAG
K874752 · CBF
Hyperbaric Aerobics, Ltd.
Anesthesiology · 76d
Cleared Feb 02, 1988
STRATUS(R) IMMUNOASSAY CONTROLS LEVELS I, II, III
K874757 · DIF
Baxter Healthcare Corp
Toxicology · 76d
Cleared Feb 02, 1988
INTEGRATED MEMBRANE OXYGENATOR W/CARDIOTOMY FILTER
K874841 · DTZ
Bentley Laboratories, Inc.
Cardiovascular · 70d
Cleared Feb 02, 1988
CATR(TM)-H CARDIOTOMY HOLDER
K874867 · KPI
Bentley Laboratories, Inc.
Gastroenterology & Urology · 67d
Cleared Feb 02, 1988
SARNS VISIFLOW AORTIC ARCH CANNULA
K874896 · DWF
3M Health Care, Sarns
Cardiovascular · 63d