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

Filters: Cleared only ×
176,076 results
174793–174816 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 31, 1977
SIMULATOR, 10 LEAD ECG
K761023 · DPS
Birtcher Corp.
Cardiovascular · 81d
Cleared Jan 31, 1977
IV SETS 2000 SERIES (HS-200,2L0,220)
K761327 · FPA
Extracorporeal Medical Specialities,...
General Hospital · 35d
Cleared Jan 31, 1977
BLACHLY BITE BLOK & CHEEK FILLER
K770090 · JXL
P.H. Blachly, M.D.
Neurology · 14d
Cleared Jan 31, 1977
MANUEL BILIRUBIN REAGENT SET
K770121 · CIG
Harleco
Chemistry · 10d
Cleared Jan 31, 1977
CENTRIFICHEM CHOLES. CALIB. STD. SET
K770126 · JIT
Union Carbide Corp.
Chemistry · 10d
Cleared Jan 31, 1977
CENTRIFICHEM 200MG/DL CHOL. CAL. STD.
K770127 · JIT
Union Carbide Corp.
Chemistry · 10d
Cleared Jan 31, 1977
AUTO-RINSE
K770152 · EHZ
Dental Innovators, Inc.
Dental · 7d
Cleared Jan 31, 1977
ALKALINE PHOSPHATASE ISOYZME REAGENT SET
K770155 · CJO
Gelman Instrument Co.
Chemistry · 7d
Cleared Jan 31, 1977
HEMOSTAT
K770158 · EMD
Deringer-Ney, Inc.
Dental · 7d
Cleared Jan 31, 1977
NEYDIUM NPFLUX (FOR SOLDERING)
K770159
Deringer-Ney, Inc.
Dental · 7d
Cleared Jan 31, 1977
CERAMIST BRUSH
K770160 · KXR
Deringer-Ney, Inc.
Dental · 7d
Cleared Jan 31, 1977
MICRO-MIX PIPETTE SHAKER
K770165 · JRQ
Maddak, Inc.
Chemistry · 6d
Cleared Jan 28, 1977
TR-3 TRANSMITTER
K760857 · DXH
Burdick Corp.
Cardiovascular · 105d
Cleared Jan 28, 1977
ISOLATION GOWN PACK
K761080 · FYC
American Hospital Supply Corp.
General Hospital · 70d
Cleared Jan 28, 1977
FILTER DEVICES
K761098 · FMI
Arrow Intl., Inc.
General Hospital · 67d
Cleared Jan 28, 1977
DOVER HYPERALIMENTATION DRESSING CHNG KT
K761099 · FRL
Will Ross Co.
General Hospital · 67d
Cleared Jan 28, 1977
RELIANCE MOD-U-LINE M-700
K761147 · FPO
F. & F. Koenigkramer
General Hospital · 63d
Cleared Jan 28, 1977
ESTILUX UV SYSTEM
K770113 · EBZ
Degussa Dental, Inc.
Dental · 9d
Cleared Jan 28, 1977
PORTA-PRO TOOTH POLISHER
K770116 · JEQ
Porta-Pro, Inc.
Dental · 9d
Cleared Jan 28, 1977
HYGIENIC 5 & 6 RUBBER DAM FRAME
K770117 · EJE
Hygienic Dental Mfg., Co., The
Dental · 7d
Cleared Jan 28, 1977
MOUTH WASH TRAY
K770120 · FMA
Pharmaseal Div., Baxter Healthcare Corp.
General Hospital · 7d
Cleared Jan 28, 1977
SPRINT S-2 INSTRU. CENTER (MODEL 92329)
K770129 · EBW
Chemetron Health Systems
Dental · 7d
Cleared Jan 28, 1977
LEW PROSTHETIC LOCKING DEVICE
K770131 · DZL
Howmedica Corp.
Dental · 7d
Cleared Jan 28, 1977
RHEUMATOID HAND GYM
K770144 · ION
Maddak, Inc.
Physical Medicine · 4d