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
137449–137472 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 25, 1987
FIAX TEST KIT FOR ENA (RNP/SM) ANTIBODIES
K873708 · LLL
Whittaker Bioproducts, Inc.
Immunology · 71d
Cleared Nov 25, 1987
SYSMEX F-800 15 PARAMETER, SEMI-AUTO HEMA ANALYZER
K873734 · GKZ
Toa Medical Electronics USA, Inc.
Hematology · 71d
Cleared Nov 25, 1987
TISSUE CULTURE TUBES
K873889 · KJA
Nunc, Inc.
Pathology · 63d
Cleared Nov 25, 1987
TISSUE CULTURE FLASKS
K873890 · KJA
Nunc, Inc.
Pathology · 63d
Cleared Nov 25, 1987
TISSUE CULTURE DISHES
K873891 · KIZ
Nunc, Inc.
Pathology · 63d
Cleared Nov 25, 1987
CREAT BRAND O-RISE GENERAL ASPIRATOR
K873940 · BTA
Aesthetech Corp.
General & Plastic Surgery · 58d
Cleared Nov 25, 1987
IRMA-COUNT FERRITIN W/MONO. ANTIBODIES RKFE1,2,5
K874031 · DBF
Diagnostic Products Corp.
Immunology · 54d
Cleared Nov 25, 1987
IQ/QCA TOTAL BILIRUBIN
K874261 · CIG
Bd Becton Dickinson Vacutainer...
Chemistry · 36d
Cleared Nov 25, 1987
MULTICHEM (R) TOTAL BILIRUBIN
K874311 · CIG
Simmler, Inc.
Chemistry · 36d
Cleared Nov 25, 1987
BAUSCH & LOMB RENU REWETTING & LUBRICATING DROPS
K874364 · LPN
Bausch & Lomb, Inc.
Ophthalmic · 33d
Cleared Nov 25, 1987
CIC-RAJI CELL REPLACEMENT ENZYME IMMUNOASSAY
K874379 · CZY
Cytotech, Inc.
Immunology · 30d
Cleared Nov 25, 1987
IGE ENZYME IMMUNOASSAY TEST KIT NO. MB-1064
K874406 · DGC
Medix Biotech, Inc.
Immunology · 28d
Cleared Nov 25, 1987
LIVE OAK ALLERGEN DISC
K874440 · DHB
Incstar Corp.
Immunology · 28d
Cleared Nov 25, 1987
EASY-TEST TOTAL PROTEIN (TP) ITEM NUMBER: 19011
K874476 · CEK
Em Diagnostic Systems, Inc.
Chemistry · 23d
Cleared Nov 25, 1987
MYCO-FLUOR REAGENT A & B
K874662 · JTS
Scott Laboratories, Inc.
Pathology · 12d
Cleared Nov 24, 1987
ELEC-TIP
K873298 · GXY
Etymotic Research
Neurology · 98d
Cleared Nov 24, 1987
TODD MEDICAL/SKILLED CARE PRODUCTS
K873499 · BTO
Todd Medical, Inc.
Anesthesiology · 85d
Cleared Nov 24, 1987
NO SPIN(TM) T3 COATED TUBE RADIOIMMUNOASSAY
K873737 · CDP
Cambridge Medical Technology
Chemistry · 70d
Cleared Nov 24, 1987
HUMID-VENT(R) 2 PORT
K873768 · BYD
Gibeck Respiration
Anesthesiology · 69d
Cleared Nov 24, 1987
GLUCOSE-HK REAGENT
K873835 · CFR
Intersect Systems, Inc.
Chemistry · 64d
Cleared Nov 24, 1987
BAXA EXACTA-MED PHARMACY PUMP
K873875 · FRN
Baxa Corp., Sub. of Cook Group, Inc.
General Hospital · 63d
Cleared Nov 24, 1987
HOT WHEELS
K873895 · ITI
Everest & Jennings, Inc.
Physical Medicine · 61d
Cleared Nov 24, 1987
IRAS GLARE TESTER
K873987 · HLJ
Randwal Instrument Co., Inc.
Ophthalmic · 56d
Cleared Nov 24, 1987
BRACHIAL PLEXUS CATHETER - BP-01200
K874105 · CAZ
Arrow Intl., Inc.
Anesthesiology · 46d