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
141913–141936 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 29, 1986
CANCELLOUS SCREW
K862990 · HRX
Orthopedic Systems, Inc.
Orthopedic · 82d
Cleared Oct 29, 1986
LIGAMENT WASHER
K862991 · HRX
Orthopedic Systems, Inc.
Orthopedic · 82d
Cleared Oct 29, 1986
HEMATALL-C PLUS HEMATOLOGY CONTROLS
K863224 · JPK
Fisher Scientific Co., LLC
Hematology · 69d
Cleared Oct 29, 1986
SENGEWALD CATALOG NUMBER 55 66 01
K863323 · KKX
Sengewald/USA, Inc.
General Hospital · 63d
Cleared Oct 29, 1986
THE FIAX 5000 FLUOROMETER
K863434 · JZT
Whittaker Bioproducts, Inc.
Immunology · 55d
Cleared Oct 29, 1986
BARD BALLOON DILATATION SYSTEM
K863437 · FGE
C.R. Bard, Inc.
Gastroenterology & Urology · 54d
Cleared Oct 29, 1986
CEREBROSPINAL FLUID PROTEIN TESTPACK, #67668/95
K863478 · JGQ
Em Diagnostic Systems, Inc.
Chemistry · 50d
Cleared Oct 29, 1986
SERACON CT REFERENCE
K863648 · JJY
Bhp Diagnostix, Inc.
Chemistry · 41d
Cleared Oct 29, 1986
EMDS URIC ACID (URC A) TESTPACK, ITEM #67664/95
K863660 · CDO
Em Diagnostic Systems, Inc.
Chemistry · 41d
Cleared Oct 29, 1986
EMDS(TM) PHOSPHORUS (PHOS) TESTPACKS, #67678/95
K863718 · CEO
Em Diagnostic Systems, Inc.
Chemistry · 36d
Cleared Oct 29, 1986
HD-100 HEMODIALYSIS SYSTEMS AND ACCESSORIES
K863720 · FIP
Water Pure, Inc.
Gastroenterology & Urology · 36d
Cleared Oct 29, 1986
NORFOLK NORPORT/SUBCUTAN. IMPLANTED DRUG DEPOT
K863723 · LJT
Norfolk Medical Products, Inc.
General Hospital · 36d
Cleared Oct 29, 1986
ENZYMUN-TEST(R) IGE
K863822 · DGC
Boehringer Mannheim Corp.
Immunology · 29d
Cleared Oct 29, 1986
IMMUNO BIOTECH'S LAMB'S QUARTERS ALLERGEN DISC
K863844 · DHB
Immuno Nuclear Corp.
Immunology · 28d
Cleared Oct 29, 1986
LOMBARD DOWELL AGAR BASE
K864014 · KZI
Gibco Laboratories Life Technologies,...
Microbiology · 14d
Cleared Oct 29, 1986
TISSUE CULTURE FLASK
K864021 · KJA
Fenwal Laboratories
Pathology · 14d
Cleared Oct 29, 1986
MICROHEMATOCRIT CENTRIFUGE
K864039 · GKF
Plaza Medical, Inc.
Hematology · 13d
Cleared Oct 29, 1986
MCARTHUR MICROSCOPE, STANDARD METAL VERSION
K864049 · IBJ
Portable Medical Laboratories, Inc.
Pathology · 12d
Cleared Oct 29, 1986
ELASTIC STAIN
K864074 · IAC
Sigma Diagnostics, Inc.
Pathology · 9d
Cleared Oct 29, 1986
URIC ACID TEST
K864119 · KNK
U. S. Diagnostics, Inc.
Chemistry · 8d
Cleared Oct 28, 1986
MODEL 2100 ND:YAG SURGICAL LASER NEUROSURGICAL IND
K861044 · GEX
Sharplan Industries, Inc.
General & Plastic Surgery · 224d
Cleared Oct 28, 1986
MODEL 4-SC FOUR WAY STOPCOCK
K863165 · FAP
Life-Tech Intl., Inc.
Gastroenterology & Urology · 71d
Cleared Oct 27, 1986
UNIVERSAL ACETABULAR COMPONENT
K861433 · JDI
Biomet, Inc.
Orthopedic · 194d
Cleared Oct 27, 1986
ESOPHAGEAL STETHOSCOPE WITH THERMISTOR
K862672 · BZT
Inmed Corp.
Anesthesiology · 105d