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
129625–129648 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 15, 1989
CHLORIDE STANDARDS ITEM #SR1041
K891999 · JIT
Em Diagnostic Systems, Inc.
Chemistry · 140d
Cleared Aug 15, 1989
MARDX LLYME DISEASE EIA (IGG & IGM) TEST SYSTEM
K892206 · LSR
Mardx Diagnostics, Inc.
Microbiology · 134d
Cleared Aug 15, 1989
KENDALL CURITY OXYGEN MASK
K892434 · BYG
The Kendal Co.
Anesthesiology · 127d
Cleared Aug 15, 1989
HIBERNATION KIT
K892660 · CAZ
Devon Industries, Inc.
Anesthesiology · 124d
Cleared Aug 15, 1989
IFA SENSIBAC GENTAMYCIN
K892720 · JTN
Investigacion Farmaceutica S.A. DE C.V.
Microbiology · 123d
Cleared Aug 15, 1989
IFA SENSIBAC PENICILLIN
K892726 · JTN
Investigacion Farmaceutica S.A. DE C.V.
Microbiology · 123d
Cleared Aug 15, 1989
CLINISTAT TOTAL BILIRUBIN REAGENT TEST
K892801 · CIG
Heraeus Kulzer, Inc.
Chemistry · 120d
Cleared Aug 15, 1989
DUBBLE BUTTERFLY PAT EXAM GLOVES/MFG: QUINGDAO FAC
K893236 · LYY
China National Chemical Construction...
General Hospital · 109d
Cleared Aug 15, 1989
PREPOWDERED VINYL EXAM GLOVES
K893334 · LYZ
Dynarex Corp.
General Hospital · 117d
Cleared Aug 15, 1989
AMERLITE TBG ASSAY, LAN.0005/1005 240/144 TEST KIT
K893469 · CEE
Amersham Corp.
Toxicology · 103d
Cleared Aug 15, 1989
INNOFLUOR CARBAMAZEPINE CALIBRATOR SET
K893506 · DLJ
Innotron of Oregon, Inc.
Chemistry · 102d
Cleared Aug 15, 1989
TWIN-FUSOR/UNI-FUSOR BLOOD & FLUID INFUSION CUFF
K893519 · KZB
Statlabs, Inc.
Microbiology · 99d
Cleared Aug 15, 1989
OTICON I22P CUSTOM FULL CONCHA (ITE) HRNG AID
K893528 · ESD
Oticon Corp.
Ear, Nose, Throat · 99d
Cleared Aug 15, 1989
BECKMAN CHOLINESTERASE REAGENT KIT
K893583 · DIH
Beckman
Chemistry · 98d
Cleared Aug 15, 1989
STERILIZATION TRAY LINER
K893764 · FRG
Ahlstrom Dexter
General Hospital · 88d
Cleared Aug 15, 1989
MODIFIED PK300 AUTOMATIC EIA ANALYZER
K893768 · JJF
Olympus Corp.
Chemistry · 88d
Cleared Aug 15, 1989
MODEL 0183010, PEARL MEDICAL EXAM LIGHT
K893807 · KZF
Burton Medical Products Corp.
General Hospital · 85d
Cleared Aug 15, 1989
MODEL 0450000, OPAL MEDICAL EXAM LIGHT
K893808 · KZF
Burton Medical Products Corp.
General Hospital · 85d
Cleared Aug 15, 1989
FD3500 (DENTAL CHAIR)
K893889 · KLC
Oriola OY Finndent
Dental · 77d
Cleared Aug 15, 1989
FD4500 (DENTAL CHAIR)
K893890 · KLC
Oriola OY Finndent
Dental · 77d
Cleared Aug 15, 1989
FD 200 DENTAL STOOL
K893943 · KLC
Oriola OY Finndent
Dental · 76d
Cleared Aug 15, 1989
FD 300 DENTAL STOOL
K893944 · KLC
Oriola OY Finndent
Dental · 76d
Cleared Aug 15, 1989
ABSOLUTE(TM)-HCG URINE PREGNANCY TEST
K893953 · DHA
Totem Diagnostics, Inc.
Chemistry · 75d
Cleared Aug 15, 1989
GRAM NEGATIVE AND POSITIVE MIC/COMBO PANELS
K893977 · JWY
Baxter Healthcare Corp
Microbiology · 74d