FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
99529–99552 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 27, 1995
MEPORE PLUS (9X15CM)
K954275 · KMF
Scott Health Care
General & Plastic Surgery · 105d
Cleared Dec 26, 1995
BIOFILL BIOCELLULOSE DRESSING STERILE
K950621 · KMF
The Purdue Frederick Co.
General & Plastic Surgery · 319d
Cleared Dec 26, 1995
CK-MB (NAC-ACT)
K951223 · CGS
Randox Laboratories, Ltd.
Chemistry · 281d
Cleared Dec 26, 1995
TRANSPORT CART
K952576 · DSP
Belmont Instrument Corp.
Cardiovascular · 204d
Cleared Dec 26, 1995
ESP CULTURE SYSTEM - MYCO
K953129 · MDB
Difco Laboratories, Inc.
Microbiology · 173d
Cleared Dec 26, 1995
RM001 REUSABLE
K953538 · HQC
American Optisurgical, Inc.
Ophthalmic · 151d
Cleared Dec 26, 1995
DM001 DISPOSABLE PACK
K953539 · HQC
American Optisurgical, Inc.
Ophthalmic · 151d
Cleared Dec 26, 1995
HYTEC AUTOIMMUNE KIT (SS-A)
K954392 · LKJ
Hycor Biomedical, Inc.
Immunology · 98d
Cleared Dec 26, 1995
DF-1 TERMINAL CAP
K954551 · DTB
Pacesetter, Inc.
Cardiovascular · 85d
Cleared Dec 26, 1995
CEDIA DAU MULTI-DR CALIBRATOR/PRI, SEC, INTER, HIGH
K954608 · DKB
Boehringer Mannheim Corp.
Chemistry · 83d
Cleared Dec 26, 1995
HYTEC AUTOMMUNE KIT (ENA)
K954890 · LLL
Hycor Biomedical, Inc.
Immunology · 62d
Cleared Dec 26, 1995
HYTEC AUTOIMMUNE KITS (SS-B)
K954891 · LKJ
Hycor Biomedical, Inc.
Immunology · 98d
Cleared Dec 26, 1995
HYTEC AUTOMIMMUNE KIT (RF)
K954892 · DHR
Hycor Biomedical, Inc.
Immunology · 62d
Cleared Dec 26, 1995
COMBIDERM ACD
K954918 · KMF
Convatec, A Bristol-Myers Squibb Co.
General & Plastic Surgery · 61d
Cleared Dec 26, 1995
EUROTROL GAS - ISE CONTROL
K955340 · JJS
Direct Solutions
Chemistry · 36d
Cleared Dec 26, 1995
THE REEL THING (MODIFICATION)
K955439 · GBX
Biomedical Devices, Inc.
General & Plastic Surgery · 43d
Cleared Dec 22, 1995
SSA-340A
K941352 · IYN
Toshiba America Medical Systems, In.C
Radiology · 641d
Cleared Dec 22, 1995
FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE AND ENDOSHEATH
K942265 · EOB
Vision-Sciences, Inc.
Ear, Nose, Throat · 592d
Cleared Dec 22, 1995
GUIDE WIRE FOR THE USE WITH DATASCOPE PERCOR STAT-DL IABS
K943896 · DQX
Datascope Corp.
Cardiovascular · 499d
Cleared Dec 22, 1995
GYROSCAN ACS-NT, GYROSCAN T5-NT AND GYROSCAN T10-NT
K945945 · LNH
Philips Medical Systems North...
Radiology · 382d
Cleared Dec 22, 1995
ENDURA REUSABLE TENS AND NMES ELECTRODES
K946230 · GZJ
Selectivemed Components, Inc.
Neurology · 365d
Cleared Dec 22, 1995
FLEXIFLO 6.1 ENTERAL NUTRITION PUMP
K951429 · LZH
Ross Products
General Hospital · 269d
Cleared Dec 22, 1995
FOCUA 90R, 90HR, 120R, 120HR, 160R, 160HR HOLLOW FIBER DIALYZER
K952343 · FJI
National Medical Care, Medical...
Gastroenterology & Urology · 217d
Cleared Dec 22, 1995
INSUL-COAT/2 CERAMIC COATED ENDO MEDICAL INSTRUMENTS
K952889 · HET
Materials Conversion Corp.
Obstetrics & Gynecology · 182d