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
133465–133488 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 26, 1988
PEDIATRIC HOSPITAL BED
K881843 · IOQ
The Medical Group, Inc.
Physical Medicine · 177d
Cleared Oct 26, 1988
CONDOMS (RAMSES, SHEIK AND KOROMEX)
K882893 · HIS
Schmid Laboratories, Inc.
Obstetrics & Gynecology · 107d
Cleared Oct 26, 1988
SMI 3000 AIRBED
K883192 · IOQ
Smi Patientcare, Inc.
Physical Medicine · 90d
Cleared Oct 26, 1988
THE SAXON SPERMICIDAL CONDOM
K883467 · HIS
Circle Rubber Corp.
Obstetrics & Gynecology · 75d
Cleared Oct 26, 1988
GILLUM'S WHEELCHAIR WIDTH REDUCING ATTACHMENT
K884052 · KNN
Professional Service Unltd.
Physical Medicine · 30d
Cleared Oct 26, 1988
MUSCLE EXAMINATION & EXERCISE DOSIMETER (MEED) SYS
K884165 · LBB
Spark Instruments & Academics, Inc.
Neurology · 22d
Cleared Oct 25, 1988
UVP VOLUMED 2001
K881079 · FRN
Ferguson Medical
General Hospital · 225d
Cleared Oct 25, 1988
PERMA PURE NAFION TUBE DRYER-MODEL ME
K881264 · CBQ
Perma Pure Products, Inc.
Anesthesiology · 215d
Cleared Oct 25, 1988
BILIRUBIN STANDARD
K882059 · JIT
Verichem Laboratories, Inc.
Chemistry · 162d
Cleared Oct 25, 1988
DISCOVER(R)
K882232 · LCX
Carter Products
Chemistry · 151d
Cleared Oct 25, 1988
REDY 2000
K882428 · FKT
Organon Teknika Corp.
Gastroenterology & Urology · 134d
Cleared Oct 25, 1988
LYPHOCHEK UNASSAYED CHEM. CONTROL (HUMAN) I AND II
K882486 · JJY
Bio-Rad
Chemistry · 131d
Cleared Oct 25, 1988
STREPSLIDE
K882811 · GTY
Ncs Diagnostics, Inc.
Microbiology · 110d
Cleared Oct 25, 1988
MYCOPLASMA PNEUMONIAE ANTIBODY LATEX TEST SYSTEM
K883083 · GSA
Medical Diagnostic Technologies, Inc.
Microbiology · 96d
Cleared Oct 25, 1988
CHEM 1 UIBC (IRON BINDING CAPACITY TEST)
K883104 · JMO
Technicon Instruments Corp.
Chemistry · 92d
Cleared Oct 25, 1988
MODEL 27084 UROMAT FOR UROLOGICAL IRRIGATION
K883173 · OCX
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 90d
Cleared Oct 25, 1988
FDL ELISA FOR CHLAMYDIA
K883266 · LJC
Fairleigh Dickinson Laboratories, Inc.
Microbiology · 83d
Cleared Oct 25, 1988
CLINISTAT DRY CHEM ANALYZER/URIC ACID REAGENT TEST
K883321 · JJE
Heraeus Kulzer, Inc.
Chemistry · 81d
Cleared Oct 25, 1988
PMD SYSTEM-20
K883390 · KMI
Datatek, Inc.
General Hospital · 77d
Cleared Oct 25, 1988
DENTA PLUS
K883403 · JER
Connoisseurs Products Corp.
Dental · 75d
Cleared Oct 25, 1988
ROCHE REAGENT FOR CALCIUM
K883453 · CJY
Roche Diagnostic Systems, Inc.
Chemistry · 74d
Cleared Oct 25, 1988
STRATUS TOTAL TRIIODOTHYRONINE T3 FLUORO. ENZYME
K883479 · CDP
Baxter Healthcare Corp
Chemistry · 70d
Cleared Oct 25, 1988
KRATZ NOVA SERT(TM)
K883489 · KYB
Coopervision-Cilco
Ophthalmic · 70d
Cleared Oct 25, 1988
OXALATE REAGENT
K883525 · LPW
Sigma Chemical Co.
Chemistry · 69d