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
144361–144384 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 07, 1986
DOUBLE ANTIBODY ALBUMIN FOR DETECT MICROALBUMINURI
K851338 · JIR
Diagnostic Products Corp.
Chemistry · 369d
Cleared Apr 07, 1986
MIRAGE INTRAVENOUS INFUSION SET OLOVSON-STERILE
K852616 · FPA
Medical Hospital Equipment
General Hospital · 299d
Cleared Apr 07, 1986
POLYCATH-H CATHETER
K854308 · FOZ
Abbott Laboratories
General Hospital · 164d
Cleared Apr 07, 1986
VICKERS MEDICAL MODEL 272 TEMPERATURE MONITOR
K854598 · FLL
Vickers , Ltd.
General Hospital · 140d
Cleared Apr 07, 1986
KODAK EKTASCAN IMAGE TRANSMISSION SYSTEM
K855002 · LLZ
Eastman Kodak Company
Radiology · 115d
Cleared Apr 07, 1986
MARQUEST QC-IV TONOMETER
K855024 · JJS
Marquest Medical Products, Inc.
Chemistry · 111d
Cleared Apr 07, 1986
MODIFIED EZ DETECT OCCULT BLOOD TEST IN STOOL
K860028 · KHE
Self Care Systems, Inc.
Hematology · 94d
Cleared Apr 07, 1986
EIA MONOCLONAL TOTAL IGE KIT
K860033 · DGC
Diagnostic Products Corp.
Immunology · 91d
Cleared Apr 07, 1986
HURWITZ DIALYSIS CATHETER
K860094 · LFJ
Gish Biomedical, Inc.
Gastroenterology & Urology · 87d
Cleared Apr 07, 1986
SYRINGE PUMP: VM 07
K860218 · FRN
Vial Medical , Ltd.
General Hospital · 75d
Cleared Apr 07, 1986
TELESCOPE PROTECTION TUBE
K860265 · KOD
R. J. Ltd., Ind.
Gastroenterology & Urology · 70d
Cleared Apr 07, 1986
DIAMATIC, AUTOMATIC INSULIN INJECTOR
K860284 · KZH
Ulster Scientific, Inc.
General Hospital · 69d
Cleared Apr 07, 1986
ACTHK-PR RIA KIT
K860311 · CKG
Compagnie Oris Industrie, S.A.
Chemistry · 69d
Cleared Apr 07, 1986
CLINISET INFUSION SET
K860322 · FPA
Zimmar Consulting , Ltd.
General Hospital · 68d
Cleared Apr 07, 1986
HGM, INC. LASERCATH (STERILE)
K860357 · LNK
Hgm, Inc.
Gastroenterology & Urology · 67d
Cleared Apr 07, 1986
CHALLENGER HOT BIOPSY FORCEPS
K860366 · KNS
Microvasive
Gastroenterology & Urology · 63d
Cleared Apr 07, 1986
FLAME PHOTOMETER STANDARD
K860501 · JLJ
Medical Specialties, Inc.
Chemistry · 55d
Cleared Apr 07, 1986
INFLATOR/DEFLATOR PISTON SYRINGE
K860589 · KNT
Microvasive
Gastroenterology & Urology · 47d
Cleared Apr 07, 1986
TRANSFER SET
K860595 · LHI
Migada, Ltd.
General Hospital · 47d
Cleared Apr 07, 1986
ALPHA-AMYLASE TEST
K860665 · JFJ
Sclavo, Inc.
Chemistry · 42d
Cleared Apr 07, 1986
ION-SPECIFIC ELECTRODE, CHLORIDE
K860668 · CGZ
Em Diagnostic Systems, Inc.
Chemistry · 42d
Cleared Apr 07, 1986
CREATINE KINASE, N-ACETYL-L-CYSTIENE
K860669 · CGS
Em Diagnostic Systems, Inc.
Chemistry · 42d
Cleared Apr 07, 1986
DRS-4 DIALYZER REPROCESSING SYSTEM
K860674 · LIF
Seratronics, Inc.
Gastroenterology & Urology · 42d
Cleared Apr 07, 1986
COMPANION 2800 VOLUME VENTILATOR REMOT ALARM
K860675 · CBK
Puritan Bennett Corp.
Anesthesiology · 42d