FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
133609–133632 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 09, 1988
ROCHE REAGENT FOR CHLORIDE
K884013 · CHJ
Roche Diagnostic Systems, Inc.
Chemistry · 78d
Cleared Dec 09, 1988
TOTAL PROTEIN REAGENT KIT FOR ASTRA SYSTEMS
K884225 · CEK
A-Kem, Inc.
Chemistry · 64d
Cleared Dec 09, 1988
AMYLASE REAGENT KIT FOR ASTRA SYSTEMS
K884226 · CJA
A-Kem, Inc.
Chemistry · 64d
Cleared Dec 09, 1988
CALIBRATOR STANDARD KIT FOR ASTRA SYSTEM
K884227 · JIX
A-Kem, Inc.
Chemistry · 64d
Cleared Dec 09, 1988
SURGEON'S GLOVE ACCESSORY
K884417 · LYY
Allied Signal, Inc.
General Hospital · 50d
Cleared Dec 09, 1988
SERUM HCG MICROASSAY
K884430 · DHA
Diamedix Corp.
Chemistry · 49d
Cleared Dec 09, 1988
MODIFIED LSF TOTAL HIP SYSTEM
K884432 · JDI
Implant Technology, Inc.
Orthopedic · 49d
Cleared Dec 09, 1988
STERILE DISPOSABLE ENDOCULAR PROBE
K884456 · GEX
Biophysic Medical, Inc.
General & Plastic Surgery · 46d
Cleared Dec 09, 1988
RUBIN BONE PLANER W/REPLACEABLE BLADE
K884473 · GAC
Neo Contemporary Co.
General & Plastic Surgery · 45d
Cleared Dec 09, 1988
FRANTZ MEDICAL SHARPS COLLECTOR
K884589 · FMF
Franklin Medical USA, Inc.
General Hospital · 36d
Cleared Dec 09, 1988
MODIFIED CEDIA TOTAL T4 ASSAY
K884634 · KLI
Microgenics Corp.
Chemistry · 32d
Cleared Dec 09, 1988
QUALTEX NEUROLOK SURGICAL SPONGE
K884790 · GDY
Deroyal Industries, Inc.
General & Plastic Surgery · 24d
Cleared Dec 08, 1988
MODIFIED IDEIA CHLAMYDIA TEST
K880799 · LJC
Boots-Celltech Diagnostics, Inc.
Microbiology · 283d
Cleared Dec 08, 1988
RETRACTABLE NEEDLE 3CC SYRINGE
K881454 · FMF
Kenmar Medical
General Hospital · 246d
Cleared Dec 08, 1988
PREEMICARE MODEL D1-X1, SERIES 3000
K881476 · FMZ
Preemicare Corp.
General Hospital · 245d
Cleared Dec 08, 1988
DELIVERY PUMP FOR STERILE IRRIGANT & HANDPIECE DR.
K882526 · EIA
Aseptico, Inc.
Dental · 191d
Cleared Dec 08, 1988
MODIFIED L.J.'S SEX HELPER
K882531 · LKY
L.J. Fant & Co.
Gastroenterology & Urology · 169d
Cleared Dec 08, 1988
ODOR-END EMERGENCY CLEAN UP POWDER
K882878 · EXB
Cdc Products Corp.
Gastroenterology & Urology · 150d
Cleared Dec 08, 1988
TRANSENDOSCOPIC ASPIRATION NEEDLE
K883093 · FBK
Endovations
Gastroenterology & Urology · 139d
Cleared Dec 08, 1988
TROJAN EXTRA STRENGTH LUBRICATED
K883413 · HIS
Carter Products
Obstetrics & Gynecology · 115d
Cleared Dec 08, 1988
IMPRA DUAL LUMEN SUBCLAVIAN - FEMORAL CATHETER
K883592 · LFJ
Impra, Inc.
Gastroenterology & Urology · 107d
Cleared Dec 08, 1988
MODIFIED SANDERS BI-PAPEASY
K883825 · BYE
Respironics, Inc.
Anesthesiology · 90d
Cleared Dec 08, 1988
TECHMEDICA I.B.O. BLADE
K883922 · DZJ
Techmedica, Inc.
Dental · 83d
Cleared Dec 08, 1988
LAKE N/G EXTENSION SET
K884128 · KNT
Lake Medical Products, Inc.
Gastroenterology & Urology · 69d