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
170761–170784 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 23, 1978
SEARLE NEONATAL OXYGEN PROBE
K780850 · CCE
Will Ross Co.
Anesthesiology · 93d
Cleared Aug 23, 1978
NEEDLES, DESIGN CHANGE, IV CATHETERS
K780896 · GCB
Jelco Laboratories
General & Plastic Surgery · 85d
Cleared Aug 23, 1978
C-DAK 4000 ARTIFICIAL KIDNEY
K781058 · FJI
Cordis Corp.
Gastroenterology & Urology · 61d
Cleared Aug 23, 1978
ACCESSORY TO ECG ANALYSIS SYS.
K781130 · OMC
Oxford Medilog, Inc.
Neurology · 49d
Cleared Aug 23, 1978
ANALYZER, PACER SYSTEM, PSA-5
K781144 · DTC
Edwards Pacemaker Systems
Cardiovascular · 44d
Cleared Aug 23, 1978
DILUTION KIT, THERMAL, COLD PAC
K781221 · DRC
Instrumentation Laboratory CO
Cardiovascular · 37d
Cleared Aug 23, 1978
TECA VS6 VIDEO STIMULATOR
K781398 · GWE
Teca, Inc.
Neurology · 8d
Cleared Aug 21, 1978
DISPOSA-LOOPS
K780548 · KKX
Medi-Spec
General Hospital · 138d
Cleared Aug 21, 1978
MODEL 65 HIGH & LOW PRESSURE ALARM
K780863 · CAP
The John Bunn Co.
Anesthesiology · 83d
Cleared Aug 21, 1978
MAGNETIC DRAPE - INSTRUMENT HOLDER
K780865 · KKX
Devon Industries, Inc.
General Hospital · 83d
Cleared Aug 21, 1978
LEE-ALLOY DISPOSABLE CAPSULES
K780966 · DZS
Lee Pharmaceuticals
Dental · 70d
Cleared Aug 21, 1978
DATA TERMINAL MODEL 722
K781217 · JQP
Corning Medical & Scientific
Chemistry · 35d
Cleared Aug 21, 1978
ALLOY, AMALGAM, DISP. CAPSULE
K781242 · EJJ
Lee Pharmaceuticals
Dental · 70d
Cleared Aug 21, 1978
BUN (UREASE) REAGENT
K781253 · CDN
Coulter Electronics, Inc.
Chemistry · 31d
Cleared Aug 21, 1978
CEMENT, DENTAL/CAVITY LINER
K781281 · EMA
Star Dental Mfg. Co.
Dental · 26d
Cleared Aug 21, 1978
ELECTRODE, NEEDLE, CFM
K781311 · GXZ
Applied Medical Research
Neurology · 21d
Cleared Aug 21, 1978
OPTION PHO/SONIC B-MODE SCANNER
K781344 · IYO
G.D. Searle and Co.
Radiology · 17d
Cleared Aug 21, 1978
CAMCO QUIK STAIN II
K781347 · IAF
Cambridge Chemical Products, Inc.
Hematology · 14d
Cleared Aug 21, 1978
IMPLANT, EYE SPHERE
K781356 · HPZ
Mcghan Medical Corp.
Ophthalmic · 14d
Cleared Aug 21, 1978
LIQUID T.B.C. MEDIUM
K781372 · JSC
Gibco Laboratories Life Technologies,...
Microbiology · 12d
Cleared Aug 21, 1978
WRIGHT RAPID STAIN
K781384 · IAF
Mfg Chemists, Inc.
Hematology · 10d
Cleared Aug 21, 1978
F.A. MOUNTING MEDIUM
K781388 · KEQ
Flow Laboratories, Inc.
Microbiology · 11d
Cleared Aug 21, 1978
BIOMET CONCENTRIC HEX SCREW
K781389 · JDO
Biomet, Inc.
Orthopedic · 11d
Cleared Aug 21, 1978
PBS FOR FA (46-991-49)
K781391 · KIP
Flow Laboratories, Inc.
Microbiology · 11d