FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
134233–134256 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 12, 1988
LAKE FOLEY CATHETERIZATION TRAY
K883610 · FCN
Lake Medical Products, Inc.
Gastroenterology & Urology · 51d
Cleared Oct 12, 1988
STERILE SURGEONS GLOVES
K883736 · KGO
Medical Manufacturers Marketing Co.
General Hospital · 41d
Cleared Oct 12, 1988
ALBABOND 60
K883758 · EJT
Degussa Dental, Inc.
Dental · 36d
Cleared Oct 12, 1988
TOTAL IRON FOR CONTINUOUS FLOW INSTRUMENTS
K883792 · JIY
Catachem, Inc.
Chemistry · 35d
Cleared Oct 12, 1988
SCEPTOR GRAM-POSITIVE BREAKPOINT/ID PANEL
K883798 · JWY
Bd Becton Dickinson Vacutainer...
Microbiology · 35d
Cleared Oct 12, 1988
SCEPTOR GRAM-NEGATIVE BREAKPOINT/ID PANEL
K883800 · JWY
Bd Becton Dickinson Vacutainer...
Microbiology · 35d
Cleared Oct 12, 1988
ACUFEX INTERFERENCE SCREW AND SCREWDRIVER
K883910 · HWC
Acufex Microsurgical, Inc.
Orthopedic · 27d
Cleared Oct 12, 1988
KVM ISOTONIC FLUSH SOLUTION
K883989 · GIF
Kvm Technologies, Inc.
Hematology · 22d
Cleared Oct 12, 1988
KVM ISOTONIC DILUENT
K883990 · GIF
Kvm Technologies, Inc.
Hematology · 22d
Cleared Oct 12, 1988
KVM HEMOGLOBIN LYSING REAGENT
K883991 · GGK
Kvm Technologies, Inc.
Hematology · 22d
Cleared Oct 12, 1988
KVM PREPACK HEMATOLOGY REAGENT SET
K883992 · GKK
Kvm Technologies, Inc.
Hematology · 22d
Cleared Oct 12, 1988
X-ACT UREA/TDA
K883995 · JSE
Pro-Lab, Inc.
Microbiology · 22d
Cleared Oct 12, 1988
X-ACT LDC/IND
K883996 · JSE
Pro-Lab, Inc.
Microbiology · 22d
Cleared Oct 12, 1988
QUIDEL GROUP A STREP TEST
K883999 · GTZ
Quidel Corp.
Microbiology · 23d
Cleared Oct 11, 1988
PROTECT-AIDS UNDERGLOVE
K880439 · LYU
Medical Armor Corp.
General Hospital · 252d
Cleared Oct 11, 1988
PROTECT-AIDS AUTOPSY UNDERGLOVE
K880440 · LYU
Medical Armor Corp.
General Hospital · 252d
Cleared Oct 11, 1988
P-7 COMPUTED TOMOGRAPHY SYSTEM
K882378 · JAK
Philips Medical Systems (Cleveland),...
Radiology · 125d
Cleared Oct 11, 1988
AMERLITE REPRODUCTIVE ENDOCRINOLOGY CONTROL SERA
K882736 · JJY
Amersham Corp.
Chemistry · 102d
Cleared Oct 11, 1988
SL SERIES ACCELERATORS SL15, SL18, SL20 & SL25
K883264 · IYE
Philips Medical Systems, Inc.
Radiology · 70d
Cleared Oct 11, 1988
FOCUS TOTAL HIP SYSTEM
K883460 · JDI
Depuy, Inc.
Orthopedic · 57d
Cleared Oct 11, 1988
TDX CANNABINOIDS-GS
K883731 · LDJ
Abbott Laboratories
Toxicology · 41d
Cleared Oct 11, 1988
EMIT D.A.U. LOW CALIBRATOR A & MEDIUM CALI. A
K883920 · DLJ
Syva Co.
Toxicology · 25d
Cleared Oct 11, 1988
EMIT D.A.U. MONOCLONAL AMPHETAMINE/METHAMPHETAMINE
K884022 · DKZ
Syva Co.
Toxicology · 19d
Cleared Oct 11, 1988
TECNOL BUCKS TRACTION W/HEEL PROTECTOR
K884132 · KQZ
Technol, Inc.
Orthopedic · 11d