Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
167017–167040 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 14, 1980
SHILEY CARDIOTOMY RESERVOIR W/FILTER
K801375 · DTP
Shiley, Inc.
Cardiovascular · 33d
Cleared Jul 14, 1980
HIPP BUFFER(NON-BARBITAL), P/N
K801378 · JJN
Gelman Sciences, Inc.
Chemistry · 33d
Cleared Jul 14, 1980
PRE-DENT SYSTEM OR PRE-DENT II
K801386 · KSS
Pre-Dent System
Hematology · 31d
Cleared Jul 14, 1980
DISC 120 TRANSPORTER
K801391 · JZW
Travenol Laboratories, S.A.
Immunology · 31d
Cleared Jul 14, 1980
GAMMADAB B-HCG RADIOIMMUNOASSAY KIT
K801409 · JHI
Travenol Laboratories, S.A.
Chemistry · 28d
Cleared Jul 14, 1980
RH CONTROL
K801425 · KSF
North American Biologicals, Inc.
Hematology · 27d
Cleared Jul 14, 1980
DISPENSING SEROLOGICAL PIPET
K801437 · JTC
Amt Corp.
Microbiology · 25d
Cleared Jul 14, 1980
P-S SURGICAL DRAIN
K801442 · GCY
Pudenz-Schulte Medical Research Corp.
General & Plastic Surgery · 24d
Cleared Jul 14, 1980
P-S SUCTION RESERVOIR
K801443 · GCY
Pudenz-Schulte Medical Research Corp.
General & Plastic Surgery · 24d
Cleared Jul 14, 1980
SKIN STAPLE REMOVER #523770
K801444 · GDT
Edward Weck, Inc.
General & Plastic Surgery · 24d
Cleared Jul 14, 1980
SKIN STAPLER HANDLE 523700/CARTRIDGES
K801445 · GAG
Edward Weck, Inc.
General & Plastic Surgery · 24d
Cleared Jul 14, 1980
OROTRACHEAL INTUBATION ENDOSCOPE
K801452 · CCW
Olympus Corp.
Anesthesiology · 21d
Cleared Jul 14, 1980
ACCU-CORE DISPOSABLE BIOPSY NEEDLE
K801457 · GAA
Medline Industries, Inc.
General & Plastic Surgery · 20d
Cleared Jul 14, 1980
MICRO CLIP STERILIZING CASE #65199
K801470 · FSM
Edward Weck, Inc.
General & Plastic Surgery · 20d
Cleared Jul 14, 1980
EZ ON SAFETY PONCHO
K801489 · KNO
Skil-Care Corp.
Physical Medicine · 18d
Cleared Jul 14, 1980
DIGOXIN EIA KIT
K801490 · LCS
M.A. Bioproducts
Toxicology · 18d
Cleared Jul 14, 1980
HI-M-TEST FOR METHADONE TEST #2
K801509 · DIW
Technam, Inc.
Toxicology · 14d
Cleared Jul 14, 1980
TIMETER PRODUCED PURRITAN BENNETT O2 ADP
K801514 · BYX
Timeter Instrument Corp.
Anesthesiology · 14d
Cleared Jul 14, 1980
PRE-DENT SYSTEM MODIFIED
K801516 · KSS
Pre-Dent System
Hematology · 13d
Cleared Jul 14, 1980
MODEL 379 WXYGEN CONCENTRATOR
K801523 · CAW
Stanley Aviation Corp.
Anesthesiology · 13d
Cleared Jul 14, 1980
LARES AIR PRESSURE GAUGE
K801534 · EIA
Lares Manufacturing Co., Inc.
Dental · 11d
Cleared Jul 14, 1980
PORTA-FIB LPD
K801544 · LDD
Narco Bio-Systems
Cardiovascular · 7d
Cleared Jul 14, 1980
MODEL R11 SINGLE CHANNEL CHART RECORDER
K801549 · DSF
Medasonics, Inc.
Cardiovascular · 7d
Cleared Jul 08, 1980
VASCULAB BI-DIRECTIONAL DOPPLER, #D10
K800768 · JAF
Medasonics, Inc.
Radiology · 92d