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
104401–104424 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 03, 1995
BIOWHITTAKER 2001 MICROPLATE READER FIRMWARE
K942245 · JJQ
Biowhittaker Molecular Applications,...
Microbiology · 329d
Cleared Apr 03, 1995
M.E.R. SURGICAL CO. OMNI INSTRUMENT SYSTEM
K944309 · GCJ
M.E.R. Surgical Co.
General & Plastic Surgery · 213d
Cleared Apr 03, 1995
GRX FOAM DRESSING
K945224 · KMF
Geritrex Corp.
General & Plastic Surgery · 159d
Cleared Apr 03, 1995
BENNETT X-RAY PROFILE POSITIONING PADDLE FOR MAMMOGRAPHY
K945962 · IZH
Bennett X-Ray Corp.
Radiology · 117d
Cleared Apr 03, 1995
SMOKIEVAC ELECTROSURGICAL PENCIL
K946104 · GEI
Aspen Laboratories, Inc.
General & Plastic Surgery · 110d
Cleared Apr 03, 1995
AURAFLEX(R) ESTRADIOL
K946199 · CHP
Organon Teknika Corp.
Chemistry · 104d
Cleared Apr 03, 1995
THERMOLASE LT-100 ND:YAG LASER HAIR REMOVAL SYSTEM
K950019 · GEX
Thermolase Corp.
General & Plastic Surgery · 90d
Cleared Apr 03, 1995
IMMULITE(R) TBG
K950072 · JJX
Diagnostic Products Corp.
Chemistry · 84d
Cleared Apr 03, 1995
SKYTRON SKYBOOM SERIES
K950192 · FQO
Skytron, Div. the Kmw Group, Inc.
General & Plastic Surgery · 75d
Cleared Apr 03, 1995
CURASORB ZN ALGINATE WOUND DRESSING
K950775 · KMF
Kendall Healthcare Products Co....
General & Plastic Surgery · 41d
Cleared Apr 03, 1995
POLYDOROS SX 65 AND 80
K950883 · IZO
Siemens Medical Solutions USA, Inc.
Radiology · 34d
Cleared Apr 03, 1995
ULTRA-PRO ULTRASOUND SCANNING TABLE MODEL #056-650
K950981 · IXR
Biodex Medical Systems, Inc.
Radiology · 31d
Cleared Apr 03, 1995
KENEX RADIATION SHIELD (VARIOUS MODELS AS EXHIBITS #2 & 5)
K951003 · KPY
Kenex , Ltd.
Radiology · 47d
Cleared Apr 03, 1995
KENEX MOBILE CASSETT HOLDER (AS EXHIBIT #7)
K951006 · IXA
Kenex , Ltd.
Radiology · 47d
Cleared Apr 03, 1995
KARL STORZ PUNCTURE, INJECTION, ENDOSCOPIC, VERESS NEEDLE
K951251 · GCJ
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 14d
Cleared Mar 31, 1995
ATTEST BRAND RAPID READOUT BIOLOGICAL IND. #129X
K926364 · FRC
3M Health Care, Ltd.
General Hospital · 829d
Cleared Mar 31, 1995
MICRO RSH HIGH SPEED HANDPIECE
K935676 · EFB
Micro Motors, Inc.
Dental · 490d
Cleared Mar 31, 1995
MAM-CH22S MAMMOGRAPHY SYSTEM WITH OPTIONAL MAMMOGUIDE STERIOTACTIC BIOPSY SYSTEM
K941353 · IZH
Elscint, Inc.
Radiology · 375d
Cleared Mar 31, 1995
R-MED DISPOSABLE PLUG
K942411 · HET
R-Med, Inc.
Obstetrics & Gynecology · 315d
Cleared Mar 31, 1995
CATCO FIRST PICC
K944504 · FOZ
Catco Medical, Inc.
General Hospital · 198d
Cleared Mar 31, 1995
CATO FIRST PICC-DUAL LUMEN
K944685 · LJS
Catco Medical, Inc.
General Hospital · 190d
Cleared Mar 31, 1995
BAXTER REINFORCED EXPANDED PTFE STEPPED VASCULAR GRAFT
K944844 · DYF
Baxter Healthcare Corp
Cardiovascular · 182d
Cleared Mar 31, 1995
TRIFLEX NON-STERILE SYNTHITIC EXAMINATION GLOVES
K944873 · LYZ
Baxter Healthcare Corp
General Hospital · 179d
Cleared Mar 31, 1995
LORAD M-IV, LORAD M-IVI
K945241 · IZH
Lorad Corp.
Radiology · 155d