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
171097–171120 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jun 22, 1978
PHONIC EAR
K780936 · EPF
Hc Electronics
Ear, Nose, Throat · 14d
Cleared Jun 22, 1978
510 BEDSIDE X-RAY SYSTEM
K780947 · IZL
Union Carbide Corp.
Radiology · 13d
Cleared Jun 22, 1978
SYSTEM, PLANNING, TREATMENT
K780948 · IWB
Emi Therapy Systems, Inc.
Radiology · 13d
Cleared Jun 22, 1978
SCISSORS, HOOK, ELECTROSURGICAL
K780954 · KNF
Kli
Obstetrics & Gynecology · 13d
Cleared Jun 22, 1978
SCISSORS, HOOK, ELECTROSURGICAL
K780955 · KNF
Kli
Obstetrics & Gynecology · 13d
Cleared Jun 22, 1978
OTOLOGICAL VENTILATION TUBES
K780956 · ETD
Mcghan Medical Corp.
Ear, Nose, Throat · 13d