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
130489–130512 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 16, 1989
SPIRO-LINK REAL TIME SPIROMETRY SYSTEM
K892121 · BZC
Biocom Intl., Inc.
Anesthesiology · 77d
Cleared Jun 16, 1989
D-CHEM(TM) T-UPTAKE TEST KIT FOR T-UPTAKE DETERMIN
K892224 · KHQ
Photec Diagnostics, Inc.
Chemistry · 74d
Cleared Jun 16, 1989
JESBERG ESOPHAGOSCOPE
K892259 · EOX
Zinnanti Surgical Instruments, Inc.
Ear, Nose, Throat · 73d
Cleared Jun 16, 1989
THE TONGUE CLEANER
K892388 · LCN
Rajiv R. Shah
Dental · 70d
Cleared Jun 16, 1989
NPG 2 BASE METAL ALLOY
K892419 · EJF
Aalba Dent, Inc.
Dental · 67d
Cleared Jun 16, 1989
PALASEAL(R)
K892452 · EBI
Kulzer, Inc.
Dental · 67d
Cleared Jun 16, 1989
KULZER INLAY SYSTEM
K892454 · EBF
Kulzer, Inc.
Dental · 67d
Cleared Jun 16, 1989
IRON SYSTEM PACK REAGENTS
K892838 · JIY
Boehringer Mannheim Corp.
Chemistry · 59d
Cleared Jun 16, 1989
GLUCOMETER QA BLOOD GLUCOSE MTR/GLUCOFILM TEST ST
K893117 · CGA
Bayer Corp.
Chemistry · 52d
Cleared Jun 16, 1989
BECKMAN EPSILON(TM) IGE REAGENT KIT
K893125 · DGO
Beckman Instruments, Inc.
Immunology · 52d
Cleared Jun 16, 1989
PHACO-INJECTOR(TM) INTRAOCULAR LENS IMPLANT INSTR
K893199 · HNR
Allergan Medical Optics
Ophthalmic · 51d
Cleared Jun 16, 1989
DIRECTIGEN 1-2-3 INFECTIOUS MONONUCLEOSIS TEST
K893737 · KTN
Quidel Corp.
Immunology · 30d
Cleared Jun 15, 1989
SHOWER STRETCHER W/WHEELS
K884759 · FPO
Linido, Inc.
General Hospital · 213d
Cleared Jun 15, 1989
INLINE AUTOTRANSFUSION SYSTEM
K890171 · CAC
Conmedcorp
Anesthesiology · 149d
Cleared Jun 15, 1989
ORTHORALIX SD/ORTHORALIX SD CEPH
K890351 · IZF
Philips Medical Systems North...
Radiology · 142d
Cleared Jun 15, 1989
CASPAR SCALP CLIP, APPLIER
K890443 · HBO
Aesculap Instruments Corp.
Neurology · 139d
Cleared Jun 15, 1989
BIVONA VENTILATOR ISOLATOR SYSTEM
K890499 · CAI
Bivona Medical Technologies
Anesthesiology · 134d
Cleared Jun 15, 1989
PREMISE SERIES BED
K890845 · FNL
Batesville American Mfg. Co.
General Hospital · 114d
Cleared Jun 15, 1989
BIOCHEM 520 BREATH INDICATOR
K890874 · CCK
Biochem International, Inc.
Anesthesiology · 114d
Cleared Jun 15, 1989
TRANSESOPHAGEAL ULTRASOUND ACCESSORIES KIT
K891180 · DXP
Ingress Technologies, Inc.
Cardiovascular · 101d
Cleared Jun 15, 1989
MIC-100 WITH CRYOPROBES
K891282 · GEH
Frigitronics of Connecticut, Inc.
General & Plastic Surgery · 98d
Cleared Jun 15, 1989
KODAK EKTASCAN IMAGE MANAGER
K891690 · LMB
Eastman Kodak Company
Radiology · 85d
Cleared Jun 15, 1989
MAGNISCAN 5000 MR SYSTEM
K891769 · LNH
General Electric Co.
Radiology · 83d
Cleared Jun 15, 1989
RUBEOLA IGG CLIN-ELISA TEST SYSTEM, CAT. #4600
K891990 · LJB
Clinical Sciences, Inc.
Microbiology · 79d