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
95593–95616 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 19, 1996
TEMPFIL F
K963786 · EBG
Sybron Dental Specialties, Inc.
Dental · 60d
Cleared Nov 19, 1996
VARIOUS SUNGLASSES (NON-PRESCRIPTION)
K963890 · HQY
Italian Eyewear, Inc.
Ophthalmic · 54d
Cleared Nov 19, 1996
RX 96E
K963891 · EJH
Jeneric/Pentron, Inc.
Dental · 54d
Cleared Nov 19, 1996
DR. BERT'S SUNCARE PRODUCTS PEEPER KEEPERS
K963955 · HQY
Bert & Joe'S, Inc.
Ophthalmic · 48d
Cleared Nov 19, 1996
FLYWAY
K963968 · HQY
Look Style, S.R.L.
Ophthalmic · 47d
Cleared Nov 19, 1996
ZOMED PASSIVE TEMPERATURE PROBE
K964286 · FLL
Zomed Intl.
General Hospital · 22d
Cleared Nov 18, 1996
HYLOC INTERFERENCE SCREW (CANNULATED)/(NON-CANNULATED)
K955733 · HWC
Depuy, Inc.
Orthopedic · 336d
Cleared Nov 18, 1996
BIOCIRCUITS IOS TSH TEST CARTRIDGES/THYROID CONTROLS
K961566 · JLW
Biocircuits Corp.
Chemistry · 209d
Cleared Nov 18, 1996
TOTAL IRON (NITRO-PAPS) REAGENT SET
K961588 · JIY
Pointe Scientific, Inc.,
Chemistry · 208d
Cleared Nov 18, 1996
ORGENTEC ANTI-RNP/SM ELISA
K962057 · LJM
American Laboratory Products Co., Ltd.
Immunology · 174d
Cleared Nov 18, 1996
ORGENTEC ANTI-SM ELISA
K962062 · LJM
American Laboratory Products Co., Ltd.
Immunology · 174d
Cleared Nov 18, 1996
SIMON NITINOL FILTER/STRAIGHT LINE SYSTEM
K963014 · DTK
Nitinol Medical Technologies, Inc.
Cardiovascular · 108d
Cleared Nov 18, 1996
SIMON NITINOL FILTER SYSTEM
K963016 · DTK
Nitinol Medical Technologies, Inc.
Cardiovascular · 108d
Cleared Nov 18, 1996
CHROMOLIZE PAI-1 KIT
K963106 · GGP
Medical Diagnostic Technologies, Inc.
Hematology · 98d
Cleared Nov 18, 1996
MINI STRIP/SERUM HCG
K963132 · JHI
International Newtech Development, Inc.
Chemistry · 98d
Cleared Nov 18, 1996
PS-UNIT CASSETTE/SERUM HCG
K963133 · JHI
International Newtech Development, Inc.
Chemistry · 98d
Cleared Nov 18, 1996
IMMULITE LATEX-SPECIFIC IGE
K963245 · DHB
Diagnostic Products Corp.
Immunology · 91d
Cleared Nov 18, 1996
PEACOCK SYSTEM
K963258 · IYE
Nomos Corp.
Radiology · 90d
Cleared Nov 18, 1996
FACT PLUS PREGNANCY TEST
K964108 · LCX
Direct Access Diagnostics
Chemistry · 34d
Cleared Nov 15, 1996
SAFECONNECT VALVE (CATALOG NO. XXXX)
K955775 · FPA
Faulding Medical Device Co.
General Hospital · 330d
Cleared Nov 15, 1996
HEARTPORT MULTIFIRE CLIP APPLIER
K961333 · DSS
Heartport, Inc.
Cardiovascular · 221d
Cleared Nov 15, 1996
HEARTPORT HANDSWITCH ELECTROCAUTERY PROBE
K961334 · GEI
Heartport, Inc.
General & Plastic Surgery · 221d
Cleared Nov 15, 1996
INTRA-AORTIC BALLOON PUMP SYSTEM 97 MODIFIED
K961509 · DSP
Datascope Corp.
Cardiovascular · 210d
Cleared Nov 15, 1996
O BUTMENT ET IMPLANT
K961665 · DZE
"O" Co., Inc.
Dental · 199d