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
139993–140016 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 05, 1987
BARD BIOPTY BIOPSY SYSTEM
K871390 · KNW
C.R. Bard, Inc.
Gastroenterology & Urology · 59d
Cleared Jun 05, 1987
OHIO(R) CARE PLUS INCUBATOR
K871399 · FMZ
Ohmeda Medical
General Hospital · 59d
Cleared Jun 05, 1987
SURVIVAL KIT, INDIV TROP TACT AIR CREW/PLASTIC BAG
K871459 · LRO
Frass Survival Systems, Inc.
General & Plastic Surgery · 53d
Cleared Jun 05, 1987
HYPERTENSION RISK DETECTOR(TM)
K871482 · DXN
Pearce Clinical Laboratories, Inc.
Cardiovascular · 52d
Cleared Jun 05, 1987
TELSTAR MODEL F3TS HEARING AID
K871518 · ESD
Telstar Electronics, Inc.
Ear, Nose, Throat · 46d
Cleared Jun 05, 1987
FULL SHELL ITE HEARING AID
K871521 · ESD
Telstar Electronics, Inc.
Ear, Nose, Throat · 46d
Cleared Jun 05, 1987
TELSTAR MODEL C HEARING AID
K871522 · ESD
Telstar Electronics, Inc.
Ear, Nose, Throat · 46d
Cleared Jun 05, 1987
MODEL NUMBER 8200 RESPIRATION/HEART RATE MONITOR
K871551 · BZQ
Aequitron Medical, Inc.
Anesthesiology · 44d
Cleared Jun 05, 1987
BIRTHING ROOM WARMER
K871594 · FMT
Air-Shields, Inc.
General Hospital · 42d
Cleared Jun 05, 1987
THE KARL STORZ MODEL 28805 ARTHRO PUMP
K871621 · HRX
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 39d
Cleared Jun 05, 1987
ELECTROTRACE DISP REST EKG ELECTRODE, CAT. ET1200
K871626 · DRX
Jason Marketing Co.
Cardiovascular · 39d
Cleared Jun 05, 1987
DOUBLE ANTIBODY CANNABINOIDS KTHD1 AND KTHD5
K871695 · LDJ
Diagnostic Products Corp.
Toxicology · 36d
Cleared Jun 05, 1987
DOUBLE ANTIBODY AMPHETAMINE KAPD1 AND KAPD5
K871696 · DKZ
Diagnostic Products Corp.
Toxicology · 36d
Cleared Jun 05, 1987
MODEL 28200C MICRO-ARTHROPLASTY SYSTEM
K871717 · HWE
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 32d
Cleared Jun 05, 1987
MODIFIED MODEL UA-751 DIGITAL SPHYGMONOMETER
K871719 · DXN
A&D Engineering, Inc.
Cardiovascular · 32d
Cleared Jun 05, 1987
MASTER MEDICAL DEVICE IS I.V. STAT 2
K871753 · FPA
The Master Medical Corp.
General Hospital · 31d
Cleared Jun 05, 1987
LIDO ACTIVE
K871793 · IKK
Loredan Biomedical, Inc.
Physical Medicine · 29d
Cleared Jun 05, 1987
DUCERAM-METAL-CERAMIC DENTAL PORCELAIN SYSTEM
K871808 · ELL
Degussa Dental, Inc.
Dental · 28d
Cleared Jun 05, 1987
IMPLANTABLE PROGRAMMABLE CARDIAC PULSE GENERATORS
K871861 · DXY
Telectronics, Inc.
Cardiovascular · 23d
Cleared Jun 05, 1987
KARL STORZ MODEL 28184 PNEUMATIC SHUTTLE SHAVER
K871891 · HSZ
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 21d
Cleared Jun 05, 1987
IMPRESSION SYRINGE
K871937 · EID
Dentsply Intl.
Dental · 18d
Cleared Jun 05, 1987
MULTICHEM TOTAL PROTEIN REAGENT #S0928
K871975 · CEK
Simmler, Inc.
Chemistry · 14d
Cleared Jun 05, 1987
MULTICHEM GLUCOSE HEXOKINASE REAGENT #S0919
K871976 · CFR
Simmler, Inc.
Chemistry · 14d
Cleared Jun 05, 1987
D-23 DENTURE ADHESIVE
K871980 · KOJ
Solar Dental Co., Inc.
Dental · 14d