FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
91561–91584 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 08, 1997
DUPLOJECT (0.5/1.0 ML, 2.0 ML, 5.0 ML)
K973510 · FMF
Immuno-U.S., Inc.
General Hospital · 83d
Cleared Dec 08, 1997
SUNGLASSES
K973528 · HQY
Jeou Jeou Long Industrial Co., Ltd.
Ophthalmic · 82d
Cleared Dec 08, 1997
SOWELL PATENTED NON-PRECIOUS METAL ALLOY
K973566 · EJH
C.K. International Trading
Dental · 80d
Cleared Dec 08, 1997
FRAG COMMANDER
K973749 · HQC
Scieran Technologies, Inc.
Ophthalmic · 68d
Cleared Dec 08, 1997
AL-47 TORIC (ISOFILCON) SOFT (TORIC) DAILY WEAR CONTACT LENS
K973847 · LPL
Martin Dalsing
Ophthalmic · 61d
Cleared Dec 08, 1997
AL-47 (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS (CLEAR &...
K973967 · LPL
Alden Optical Labs., Inc.
Ophthalmic · 52d
Cleared Dec 08, 1997
RANDOX BILIRUBIN
K973995 · GIG
Randox Laboratories, Ltd.
Chemistry · 48d
Cleared Dec 08, 1997
AMYLASE-SL ASSAY CATALOGUE NUMBER 341-10
K974053 · JFJ
Diagnostic Chemicals , Ltd.
Chemistry · 42d
Cleared Dec 08, 1997
CHIRON DIAGNOSTICS ACS:180 MYOGLOBIN
K974325 · DDR
Chiron Diagnostics Corp.
Chemistry · 20d
Cleared Dec 08, 1997
ELECSYS CALCHECK VITAMIN B12
K974383 · JJX
Boehringer Mannheim Corp.
Chemistry · 17d
Cleared Dec 08, 1997
ELECSYS CALCHECK FOLATE
K974384 · JJY
Boehringer Mannheim Corp.
Chemistry · 17d
Cleared Dec 08, 1997
MULTI
K974414 · HQY
Morning Calm Corp.
Ophthalmic · 14d
Cleared Dec 05, 1997
ACIST ANGIOGRAPHIC INJECTOR
K963982 · DXT
Invasatec
Cardiovascular · 429d
Cleared Dec 05, 1997
MERIDIAN TITANIUM FEMORAL STEMS
K972228 · LZO
Howmedica, Inc.
Orthopedic · 175d
Cleared Dec 05, 1997
THE THERATEST EL-B2GP1 (IGM, IGG, IGA) AND EL-B2GP1SCR
K972790 · MSV
Theratest Laboratories, Inc.
Immunology · 130d
Cleared Dec 05, 1997
ACCESS RADIOLOGY (FRAMEWAVE) TELERADIOLOGY IMAGE ACQUISITION AND DISTRIBUTION...
K972925 · LMD
Access Radiology Corp.
Radiology · 119d
Cleared Dec 05, 1997
ADVANTAGE 3000
K973355 · IKN
Advantage Medical Division of Cme...
Neurology · 88d
Cleared Dec 05, 1997
ETHICON NON-STICK BIPOLAR FORCEPS
K973384 · GEI
Ethicon, Inc.
General & Plastic Surgery · 88d
Cleared Dec 05, 1997
OVAL SHAPES
K973385 · HXA
Technical Products, Inc.
Orthopedic · 88d
Cleared Dec 05, 1997
IMAGESHARE COMPUTED RADIOGRAPHY ACQUISITION STATION AND/OR...
K973421 · LMD
Dejarnette Research Systems
Radiology · 86d
Cleared Dec 05, 1997
STERI-OSS 3.25 MM REPLACE(HYDROXYAPATITE-COATED)DENTAL IMPLANT
K973423 · DZE
Steri-Oss, Inc.
Dental · 86d
Cleared Dec 05, 1997
STERI-OSS 3.25 MM REPLACE(TITANIUM PLASMA SPRAYED) DENTAL IMPLANT
K973433 · DZE
Steri-Oss, Inc.
Dental · 86d
Cleared Dec 05, 1997
TROPONIN I ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
K973616 · MMI
Bayer Corp.
Chemistry · 73d
Cleared Dec 05, 1997
CP BREAST ARRAY COIL/MAGNETOM HARMONY/SYMPHONY SYSTEM
K973630 · MOS
Siemens Medical Solutions USA, Inc.
Radiology · 72d