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
155833–155856 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 24, 1983
PERCUTANEOUS INTRODUCER KIT
K831636 · DQY
Accu-Line
Cardiovascular · 93d
Cleared Aug 24, 1983
THERMOMIXER S213-PHOTOANALYZER S263
K831649 · JJE
Texas Intl. Laboratories, Inc.
Chemistry · 93d
Cleared Aug 24, 1983
ALKA FIRST AID KIT
K831657 · FRO
Alka, Inc.
General & Plastic Surgery · 93d
Cleared Aug 24, 1983
ORTHO*PAP-IA ENDOGENOUS ENZYME IMMUNO
K831670 · JFH
Ortho Diagnostic Systems, Inc.
Chemistry · 93d
Cleared Aug 24, 1983
TEMPERATURE MODULE 242-100
K831733 · FLL
Kontron Instruments, Inc.
General Hospital · 85d
Cleared Aug 24, 1983
PER-Q-CATH TRAY
K831845 · LJS
Gesco Intl., Inc.
General Hospital · 77d
Cleared Aug 24, 1983
IONOPHORELIC SWEAT STIM. CHLORIDE-
K832059 · KTB
Medtronic Vascular
Chemistry · 58d
Cleared Aug 24, 1983
TITAN GEL GLYCO-HEME SYSTEM
K832087 · LCP
Helena Laboratories
Hematology · 57d
Cleared Aug 24, 1983
SANDARE CALCIUM PROCEDURE
K832183 · CIC
Sandare Chemical Co., Inc.
Chemistry · 49d
Cleared Aug 24, 1983
PB 600 REPEATING DISPENSER
K832202 · JQW
Hamilton Co.
Chemistry · 48d
Cleared Aug 24, 1983
MICROLAB P
K832204 · JQW
Hamilton Co.
Chemistry · 48d
Cleared Aug 24, 1983
PRECISION LIQUID DISPENSER
K832205 · JQW
Hamilton Co.
Chemistry · 48d
Cleared Aug 24, 1983
SPECTROPHOTOMETER #390
K832206 · JJQ
Abbott Diagnostics
Toxicology · 48d
Cleared Aug 24, 1983
KINETI COUNT 24 GAMMA COUNTER
K832209 · JJJ
Medical & Scientific Designs, Inc.
Chemistry · 48d
Cleared Aug 24, 1983
GAMMA PHOTON GAMMA COUNTER
K832210 · JJJ
Medical & Scientific Designs, Inc.
Chemistry · 48d
Cleared Aug 24, 1983
PRECISET CHOLESTEROL HIGH PERFORM
K832251 · JIS
Boehringer Mannheim Corp.
Chemistry · 44d
Cleared Aug 24, 1983
SPS DISCS
K832305 · JTO
Oxoid U.S.A., Inc.
Microbiology · 41d
Cleared Aug 24, 1983
BILE AESCULIN DISCS
K832306 · JTO
Oxoid U.S.A., Inc.
Microbiology · 41d
Cleared Aug 24, 1983
STERILE IV SET 4 SIZES
K832329 · FPA
Abco Dealers, Inc.
General Hospital · 40d
Cleared Aug 24, 1983
DYNACOR CONNECTING TUBING
K832398 · BYY
Medline Industries, Inc.
General Hospital · 35d
Cleared Aug 18, 1983
AOR X-RAY ALIGMENT PAD
K837776 · IXJ
Zimmer, Inc.
Radiology · 229d
Cleared Aug 16, 1983
FITKIT I CHECKUP KIT
K821799 · CDM
Patton, Boggs & Blow
Chemistry · 424d
Cleared Aug 16, 1983
FITKIT I CHECKUP KIT
K830340 · CDM
Boditestor
Hematology · 195d
Cleared Aug 16, 1983
AMBULATORY MARK III INFUSION DEVICE
K830656 · FRN
Windsor Medical, Inc.
General Hospital · 167d