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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
128857–128880 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 04, 1989
MODEL 280 INFUSION PUMP
K894360 · FRN
3M Company
General Hospital · 82d
Cleared Oct 04, 1989
ORTHO RESULT PLUS/PREGNANCY
K894420 · JHI
Ortho Diagnostic Systems, Inc.
Chemistry · 79d
Cleared Oct 04, 1989
WOLDOFF PRISMATIC BICONCAVE LENS
K894421 · HJK
Ocular Instruments, Inc.
Ophthalmic · 79d
Cleared Oct 04, 1989
TECHNICON RA SYSTEM THYROXINE T4 METHOD
K894575 · CDX
Technicon Instruments Corp.
Chemistry · 75d
Cleared Oct 04, 1989
MASCOT EXAMINATION GLOVES
K894587 · LYY
Mascot, Inc.
General Hospital · 72d
Cleared Oct 04, 1989
LATEX EXAMINATION GLOVES
K894677 · LYY
Kumpulan Santra (Penang) Sdn. Bhd.
General Hospital · 72d
Cleared Oct 04, 1989
NIDEK MODEL ADC-8000
K894709 · GEX
Nidek, Inc.
General & Plastic Surgery · 72d
Cleared Oct 04, 1989
DELFIA PLATE FLUOROMETER 1232
K895240 · KHO
Pharmacia, Inc.
Chemistry · 44d
Cleared Oct 04, 1989
LATEX EXAMINATION GLOVES
K895332 · LYY
Ever Glory Intl., Inc.
General Hospital · 34d
Cleared Oct 04, 1989
ANTI-SS-A (RO) AND ANTI-SS-B (LA) ANTIBODY TEST
K895339 · LLL
Immco Diagnostics, Inc.
Immunology · 34d
Cleared Oct 04, 1989
ACCESS CHEMISTRY ANALYZER
K895423 · JJE
American Monitor Corp.
Chemistry · 27d
Cleared Oct 04, 1989
NON-MYDRIATIC RETINAL CAMERA, CR4-45NM DUAL
K895474 · HKI
Canon USA, Inc.
Ophthalmic · 23d
Cleared Oct 04, 1989
STRATUS(R) GENTAMICIN FLUOROMETRIC ENZYME IMMUNO.
K895484 · LCD
Baxter Healthcare Corp
Toxicology · 23d
Cleared Oct 04, 1989
QCLYTE PROTEIN-BASED ISE CONTROL
K895582 · JJR
Baxter Healthcare Corp
Chemistry · 19d
Cleared Oct 04, 1989
NIL PATIENT EXAMINATION GLOVES
K895641 · LYY
United Lion Rubber Industries Sdn. Bhd.
General Hospital · 15d
Cleared Oct 03, 1989
ERGOMED 840/ERGOMED 840L
K885085 · DRT
Burdick Corp.
Cardiovascular · 298d
Cleared Oct 03, 1989
SYRINGE INJECTION GUN DELIVERY KITS
K890658 · LRO
Gastrotech, Inc.
General & Plastic Surgery · 237d
Cleared Oct 03, 1989
BIOPSY FORCEPS
K892252 · FCL
Zinnanti Surgical Instruments, Inc.
Gastroenterology & Urology · 182d
Cleared Oct 03, 1989
MINI ACCELOGRAPH NEUROMUSCULAR TRANS. MONITOR
K892396 · BXN
Biometer Intl. A/S
Anesthesiology · 179d
Cleared Oct 03, 1989
BAXTER ACETONE-ALCOHOL PREP PADS, STERILE
K893958 · LKB
Span-America Medical Systems, Inc.
General Hospital · 124d
Cleared Oct 03, 1989
THERMOSURGERY TM
K894166 · GEI
Rdm Intl., Inc.
General & Plastic Surgery · 110d
Cleared Oct 03, 1989
GX-ELEVATOR
K894188 · IZZ
Gendex Corp.
Radiology · 109d
Cleared Oct 03, 1989
MEDICAL DYNAMICS LIGHT SOURCE
K894319 · FSW
Medical Dynamics, Inc.
General & Plastic Surgery · 81d
Cleared Oct 03, 1989
SALTER LABS MODEL #4009 SAMPLE LINES
K894350 · CCK
Salter Labs
Anesthesiology · 81d