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
133393–133416 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 04, 1989
PALGAFLEX AND PALGAFLEX-QUICK
K884381 · ELW
Espe GmbH (Us)
Dental · 78d
Cleared Jan 04, 1989
VOYAGER/X
K884754 · NFB
Smith-Perry Corp.
Anesthesiology · 51d
Cleared Jan 04, 1989
BERICHROM(R) PLASMINOGEN
K884766 · DDX
Behring Diagnostics, Inc.
Immunology · 51d
Cleared Jan 04, 1989
ONCOPROBE SYSTEM
K884770 · IZD
Care Wise Medical Products Corp.
Radiology · 51d
Cleared Jan 04, 1989
TWIXEL(TM)
K885056 · JES
Fouts Development, Inc.
Dental · 28d
Cleared Jan 04, 1989
IGE FASTSCREEN S6 (F1, F2, F4, F13, F14)
K885065 · DHB
3M Company
Immunology · 29d
Cleared Jan 04, 1989
AFFINITY(TM) FERRITIN IMMUNIT(TM)
K885074 · DBF
Bd Becton Dickinson Vacutainer...
Immunology · 27d
Cleared Jan 03, 1989
-AMYLASE EPS
K882225 · CIJ
Boehringer Mannheim Corp.
Chemistry · 222d
Cleared Jan 03, 1989
AUTO IMPEDANCE METER AE105 & AE106 W/AUDIOMETER
K883728 · ETY
American Electromedics Corp.
Ear, Nose, Throat · 125d
Cleared Jan 03, 1989
MODIFIED TSH IRMA KIT
K883742 · JLW
Pacific Biotech, Inc.
Chemistry · 124d
Cleared Jan 03, 1989
AUTOMATED EIA READER MODEL EL311
K884124 · JJQ
Bio-Tek Instruments, Inc.
Chemistry · 95d
Cleared Jan 03, 1989
HEARING AID, UNITRON BTE MODEL UM60-AGC0
K884288 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 83d
Cleared Jan 03, 1989
UNIREST COMPOSITE RESTORATIVE, SELF CURED
K884350 · EBF
Scientific Pharmaceuticals, Inc.
Dental · 81d
Cleared Jan 03, 1989
PREMET, METAL PRIMER
K884391 · EBF
Scientific Pharmaceuticals, Inc.
Dental · 77d
Cleared Jan 03, 1989
MAXIBOND
K884575 · DYH
Ortho Source
Dental · 63d
Cleared Jan 03, 1989
OPHTHASCAN MINI-B
K884595 · IYO
Biophysic Medical, Inc.
Radiology · 61d
Cleared Jan 03, 1989
UNIREST LC PAINT-ON RESTORATIVE & VENEER CEMENT
K884681 · EBF
Scientific Pharmaceuticals, Inc.
Dental · 56d
Cleared Jan 03, 1989
GLUCOSE-HK TEST (GLUC-HK) ITEM #65665
K884736 · CFR
Em Diagnostic Systems, Inc.
Chemistry · 50d
Cleared Jan 03, 1989
GLUCOSE LIQUID AMRESCO #4628300 & 4628001L
K884909 · CGA
American Research Products Co.
Chemistry · 41d
Cleared Jan 03, 1989
ALANINE AMINOTRANSFERASE
K884936 · CKA
Catachem, Inc.
Chemistry · 39d
Cleared Dec 30, 1988
TRANSFER CONTAINER HUMIDIFIER
K881648 · CAF
Newport Biosystems, Inc.
Anesthesiology · 259d
Cleared Dec 30, 1988
INFUSION PUMP
K882830 · LZF
Pemlab Corp.
General Hospital · 175d
Cleared Dec 30, 1988
DADE FACTOR VIII CHROMOGENIC ASSAY
K884544 · GGP
Baxter Healthcare Corp
Hematology · 60d
Cleared Dec 30, 1988
DADE FACTOR IX CHROMOGENIC ASSAY
K884551 · GGP
Baxter Healthcare Corp
Hematology · 60d