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
160729–160752 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 26, 1982
ACCU-RYNGE INSULIN PUMP #SP-250
K820482 · FRN
Delta Medical Industries
General Hospital · 32d
Cleared Mar 26, 1982
SODIUM PYRUVATE (100MM)
K820495 · KIT
Dutchland Laboratories, Inc.
Chemistry · 31d
Cleared Mar 26, 1982
MEM NON-ESSENTIAL AMINO ACIDS (100X)
K820508 · KIT
Dutchland Laboratories, Inc.
Chemistry · 31d
Cleared Mar 26, 1982
7CM BERMAN AIRWAY
K820512 · CAE
Vital Signs, Inc.
Anesthesiology · 29d
Cleared Mar 26, 1982
PFLEX TM
K820528 · BWF
Health Scan, Inc.
Anesthesiology · 25d
Cleared Mar 26, 1982
WET PACK LINE OF PRODUCTS
K820587 · KMJ
Abco Dealers, Inc.
General Hospital · 22d
Cleared Mar 26, 1982
ORTHOPEDIC SOFT GOODS
K820590 · ILI
Abco Dealers, Inc.
Physical Medicine · 22d
Cleared Mar 26, 1982
CYANMETHEMOGLOBIN TEST
K820596 · KHG
Boehringer Mannheim Corp.
Hematology · 22d
Cleared Mar 26, 1982
158 BLOOD GAS ANALYZER
K820597 · CHL
Corning Medical & Scientific
Chemistry · 22d
Cleared Mar 26, 1982
ANGIOTENSIS I-SQUIBB RADIOIMMUNOASSAY
K820616 · CIB
E. R. Squibb & Sons, Inc.
Toxicology · 18d
Cleared Mar 26, 1982
TRICHROME STAIN
K820634 · HYC
Volu Sol Medical Industries
Pathology · 18d
Cleared Mar 26, 1982
STORZ #6500 POWER EXAMINATION CHAIR
K820636 · GBB
Storz Instrument Co.
General & Plastic Surgery · 18d
Cleared Mar 26, 1982
HOO2D SEAT-INFANT
K820640 · BYL
Dhd Medical Products Div. Diemolding...
Anesthesiology · 18d
Cleared Mar 26, 1982
BALLARD MEDICAL PRODUCTS ELECTRO-SURG
K820713 · GEI
Ballard Medical Products
General & Plastic Surgery · 11d
Cleared Mar 25, 1982
HYPODERMIC & SUTURE NEEDLES
K813256 · FMI
Needle Industries(Usa), Inc.
General Hospital · 126d
Cleared Mar 25, 1982
SALICYLATES
K813431 · DKJ
Bio-Analytics Laboratories, Inc.
Toxicology · 107d
Cleared Mar 25, 1982
AUTO SECTOR MCU
K813596 · IYO
Technicare Corp.
Radiology · 87d
Cleared Mar 25, 1982
CONTINUOUS BLOOD PROCESSOR CBP-6000 &
K820243 · KDI
Bentley Laboratories, Inc.
Gastroenterology & Urology · 55d
Cleared Mar 25, 1982
ELECTRONIC DIGITAL SPHYGMOMANOMETER
K820300 · DXN
Copal, Inc.
Cardiovascular · 49d
Cleared Mar 25, 1982
FETAL-TEK CONTROL MATURE
K820319 · JJS
Helena Laboratories
Chemistry · 48d
Cleared Mar 25, 1982
LUTEINIZING HORMONE KIT
K820357 · CEP
Pcl-Ria, Inc.
Chemistry · 44d
Cleared Mar 25, 1982
PROFILE GENERAL SET ASSAYED SERUM CONTR
K820468 · DIF
General Diagnostics
Toxicology · 31d
Cleared Mar 25, 1982
RELIEF VALVE-HONAN INTRAOC. PRESSURE
K820526 · LCC
The Lebanon Corp.
Ophthalmic · 27d
Cleared Mar 25, 1982
DECUBICARE PADS & ACCESSORIES
K820584 · FMP
Abco Dealers, Inc.
General Hospital · 21d