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.

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

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175,820 results
139201–139224 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 18, 1987
POROCOAT (R) PROXIMAL FEMORAL THIRD PROSTHESIS
K872025 · KWL
Depuy, Inc.
Orthopedic · 84d
Cleared Aug 18, 1987
SYSTEM PACK FOR B.M.D/HITACHI 704 CHEM. ANA.(GABA)
K872306 · CIC
Boehringer Mannheim Corp.
Chemistry · 64d
Cleared Aug 17, 1987
ZINDRICK IM ROD
K871539 · HSB
Buckman Co., Inc.
Orthopedic · 119d
Cleared Aug 17, 1987
OLYMPUS GF-UM2/EU-M2
K872027 · IYO
Olympus Corp.
Radiology · 83d
Cleared Aug 17, 1987
IMMUBEAD THYROID UPTAKE
K872172 · KHQ
Immunotech Corp.
Chemistry · 70d
Cleared Aug 17, 1987
COOPER SURG ASPIRATION CANNULA/CUSTOM CONVEN PAKS
K872214 · GEA
CooperVision, Inc.
General & Plastic Surgery · 69d
Cleared Aug 17, 1987
MODIFIED TROCHANTER CABLE GRIP SYSTEM
K872224 · KTT
Howmedica Corp.
Orthopedic · 69d
Cleared Aug 17, 1987
AIRE-CUF POLYESTER RE-ENFORCED ENDOTRACHEAL TUBE
K872366 · BTR
Bivona Medical Technologies
Anesthesiology · 60d
Cleared Aug 17, 1987
INNOTRON INNOFLUOR TOBRAMYCIN REAGENT SET
K872562 · LFW
Innotron of Oregon, Inc.
Chemistry · 54d
Cleared Aug 17, 1987
INNOFLUOR VANCOMYCIN REAGENT SET
K872579 · LEH
Innotron of Oregon, Inc.
Chemistry · 48d
Cleared Aug 17, 1987
BION ANTINUCLEAR ANTIBODY(ANA)TEST KIT/CONTR SERUM
K872845 · DHN
Bion Ent., Ltd.
Immunology · 28d
Cleared Aug 17, 1987
BIOPRO 32MM BALL
K872856 · JDI
Biopro, Inc.
Orthopedic · 27d
Cleared Aug 17, 1987
ACE CANCELLOUS BONE SCREW
K872859 · HWC
Ace Medical Co.
Orthopedic · 27d
Cleared Aug 17, 1987
TRIGLYCERIDE (UV) REAGENT
K872912 · JGW
Sigma Chemical Co.
Chemistry · 24d
Cleared Aug 17, 1987
MICRINS SURGICAL SCISSOR
K872990 · FZT
Micrins Surgical, Inc.
General & Plastic Surgery · 17d
Cleared Aug 17, 1987
MICRINS FORCEPS 2010
K872991 · GEN
Micrins Surgical, Inc.
General & Plastic Surgery · 17d
Cleared Aug 17, 1987
MIN-IDENTOFLEX
K873002 · EHJ
Centrix, Inc.
Dental · 13d
Cleared Aug 17, 1987
CONCEPT SWITCHING STICK
K873009 · KGZ
Concept, Inc.
General & Plastic Surgery · 13d
Cleared Aug 14, 1987
ANDRIES PHYSICAL ASSESSMENT COMPUTER
K870545 · DQC
Andries Tek, Inc.
Cardiovascular · 185d
Cleared Aug 14, 1987
MASCOT CW DOPPLER SYSTEM
K871212 · JOP
Imex Medical Systems, Inc.
Cardiovascular · 141d
Cleared Aug 14, 1987
FREEZING MEDIUM (TEST YOLK BUFFER W/GLYCEROL)
K872088 · HDR
Irvine Scientific
Obstetrics & Gynecology · 74d
Cleared Aug 14, 1987
APACERAM HYDROXYLAPATITE DENTAL IMPLANT (TYPE G)
K872089 · DZE
Asahi Optical Co. C/O Rosati...
Dental · 74d
Cleared Aug 14, 1987
CAT. #9972 REFRIGERATION MEDIUM (TEST YOLK BUFFER)
K872203 · HDR
Irvine Scientific
Obstetrics & Gynecology · 67d
Cleared Aug 14, 1987
CLARIFIED APPLICA. FOR LACEY CONDYLAR TOTAL KNEE
K872266 · JWH
Dow Corning Wright
Orthopedic · 73d