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
129649–129672 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 15, 1989
HGB-CAL SET/MULTIPLE
K893984 · KRZ
R&D Systems, Inc.
Hematology · 71d
Cleared Aug 15, 1989
HGB-CONTROL SET/MULTIPLE
K893985 · GGM
R&D Systems, Inc.
Hematology · 71d
Cleared Aug 15, 1989
LEECO VIS-DISK STREP-A (EIA)
K894122 · GTZ
Leeco Diagnostics, Inc.
Microbiology · 64d
Cleared Aug 15, 1989
ROBOTIC SAMPLE PROCESSOR
K894126 · JQW
Tecan U.S., Ltd.
Chemistry · 64d
Cleared Aug 15, 1989
RUBBER TREE BRAND
K894214 · LYY
Jinmei International, Inc.
General Hospital · 57d
Cleared Aug 15, 1989
MERIVIEW TM TRICHOMONAS
K894246 · JWZ
Meridian Diagnostics, Inc.
Microbiology · 55d
Cleared Aug 15, 1989
KDF-2.3
K894264 · HDR
Unimar, Inc.
Obstetrics & Gynecology · 56d
Cleared Aug 15, 1989
DENLEY WELLWASH 2 AND 4
K894271 · JQW
Denley Instruments, Inc.
Chemistry · 54d
Cleared Aug 15, 1989
LUTEINIZING HORMONE MAB SOLID PHASE COMPONENT SYST
K894279 · CEP
Bd Becton Dickinson Vacutainer...
Chemistry · 53d
Cleared Aug 15, 1989
DIDECO-SHILEY UNIVERSAL Y
K894294 · CAC
Shiley, Inc.
Anesthesiology · 53d
Cleared Aug 15, 1989
MODEL DT-IUPC2 TRANSDUCER TIPPED DUAL LUMEN IUP
K894362 · KXO
Spectramed, Inc.
Obstetrics & Gynecology · 32d
Cleared Aug 15, 1989
DECONTAMINATING KIT, SKIN: M291
K894455 · MAC
Dept. of the Army
General Hospital · 21d
Cleared Aug 15, 1989
ABUSCREEN RADIOIMMUNOASSAY FOR METHAMPHETAMINE
K894465 · DKZ
Roche Diagnostic Systems, Inc.
Toxicology · 26d
Cleared Aug 15, 1989
DALE I.V. IDENTIFIER
K894586 · KMK
Dale Medical Products, Inc.
General Hospital · 22d
Cleared Aug 15, 1989
CHLAMYDIA (LGV-1)
K894625 · LKI
Bion Ent., Ltd.
Microbiology · 26d
Cleared Aug 11, 1989
CONDOMS
K880819 · HIS
Universal Trade, Inc.
Obstetrics & Gynecology · 532d
Cleared Aug 11, 1989
ANESTHETIC GAS MONITOR
K890446 · CBS
Bruel & Kjaer Instruments, Inc.
Anesthesiology · 196d
Cleared Aug 11, 1989
DENTANURSE
K891607 · EMA
The Irish Scene
Dental · 144d
Cleared Aug 11, 1989
PATIENT EXAM GLOVES (MFG. TA TA INDUSTRIAL CO.)
K892473 · LYY
Mccampbell Ent. Unltd., Inc.
General Hospital · 126d
Cleared Aug 11, 1989
TRACER DYNAMIC AXIAL FIXATION
K892638 · JEC
Tracer Medical
Orthopedic · 121d
Cleared Aug 11, 1989
XENOS MOBILECAM
K893379 · IYX
Xenos Medical Systems, Inc.
Radiology · 102d
Cleared Aug 11, 1989
INNOFLUOR CARBAMAZEPINE REAGENT SET
K893507 · KLT
Innotron of Oregon, Inc.
Chemistry · 98d
Cleared Aug 11, 1989
GE SIGNA ADVANTAGE
K893509 · LNH
GE Medical Systems
Radiology · 98d
Cleared Aug 11, 1989
T3 CLASP-BEAD EIA KIT
K893620 · CDP
Biotecx Laboratories, Inc.
Chemistry · 92d