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

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176,076 results
171937–171960 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 22, 1978
MASK, SURGEONS
K780607 · FXX
Abco Dealers, Inc.
General Hospital · 73d
Cleared Jun 22, 1978
SINGLE PATIENT SYSTEMS
K780682 · FKP
Extracorporeal Medical Specialities,...
Gastroenterology & Urology · 59d
Cleared Jun 22, 1978
AUTO SUTURE DISPOSABLE STAPLING INSTRU.
K780695 · GDW
United States Surgical, A Division of...
General & Plastic Surgery · 59d
Cleared Jun 22, 1978
ANTICONVULSANTS III CALIBRATOR KIT
K780733 · DKH
Vitek Systems, Inc.
Toxicology · 51d
Cleared Jun 22, 1978
ANTICONVULSANTS II CALIBRATOR KIT
K780734 · DIY
Vitek Systems, Inc.
Toxicology · 51d
Cleared Jun 22, 1978
PROSTHESIS, HIP, CATHCART, SCHILLER MOD.
K780773 · JDG
Depuy, Inc.
Orthopedic · 49d
Cleared Jun 22, 1978
IRRIGATION CATHETER
K780788 · GBX
Shiley, Inc.
General & Plastic Surgery · 38d
Cleared Jun 22, 1978
IDI 200 GAMMA COUNTER
K780790 · JJJ
Iso-Data, Inc.
Radiology · 38d
Cleared Jun 22, 1978
ZYTRON
K780796 · EBF
Premier Dental Products Co.
Dental · 38d
Cleared Jun 22, 1978
LAPOROTOMY SPONGE
K780806 · EFQ
Abco Dealers, Inc.
General & Plastic Surgery · 43d
Cleared Jun 22, 1978
PIEZOMATIC ULTRASONIC SCALER (SYSTEM S)
K780808 · ELC
Dental Ventures of America, Inc.
Dental · 35d
Cleared Jun 22, 1978
DENTAL ABRASIVE DEVICE
K780811 · EHL
Cavitron Corp.
Dental · 35d
Cleared Jun 22, 1978
LAPAROTOMY SPONGE
K780818 · EFQ
Qualtex, Inc.
General & Plastic Surgery · 36d
Cleared Jun 22, 1978
SYSING AND HEMOGLOBIN REAGENT
K780829 · GKR
Harleco
Hematology · 34d
Cleared Jun 22, 1978
ARANTROL
K780835 · JPK
Aranco Diagnostic Laboratories, Inc.
Hematology · 30d
Cleared Jun 22, 1978
PRINCETON BIOMEDIX HEXOKINASE, GLUCOSE
K780858 · CFR
Bd Becton Dickinson Vacutainer...
Chemistry · 29d
Cleared Jun 22, 1978
RIA SYSTEM FOR HUMAN F-S HORMONE
K780870 · CGJ
Calbiochem-Behring Corp.
Chemistry · 23d
Cleared Jun 22, 1978
EMIT CLINICAL PROCESSOR - CP 5000
K780881 · JQP
Syva Co.
Chemistry · 23d
Cleared Jun 22, 1978
IMPROVED DISPOSABLE HYPODERMIC NEEDLE
K780887 · GAA
Pharmaseal Div., Baxter Healthcare Corp.
General & Plastic Surgery · 27d
Cleared Jun 22, 1978
KNEE, TOTAL, FEMORAL & TIBIAL
K780904 · MBV
Depuy, Inc.
Orthopedic · 23d
Cleared Jun 22, 1978
MIC-2000
K780907 · JSF
Gibco Laboratories Life Technologies,...
Microbiology · 20d
Cleared Jun 22, 1978
ADDITIONAL REAGENTS KITS FOR IMM. SYSTEM
K780913 · DCF
Beckman Instruments, Inc.
Immunology · 17d
Cleared Jun 22, 1978
ELECTROSURGICAL GROUNDING PAD CABLE
K780924 · GEI
Johnson & Johnson Professionals, Inc.
General & Plastic Surgery · 17d
Cleared Jun 22, 1978
EB-VCA, TEST, ANTIBODY, FLUORESCENT
K780925 · JRY
Litton Bionetics
Microbiology · 16d